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PRACTICE GUIDELINES FOR THE DIAGNOSIS AND MANAGEMENT OF ASPERGILLOSIS: 2016 UPDATE BY THE INFECTIOUS DISEASES SOCIETY OF AMERICA§Thomas F. Patterson1+*, George R. Thompson III2, David W. Denning3, Jay A. Fishman4, Susan Hadley5, Raoul Herbrecht6, Dimitrios P. Kontoyiannis7, Kieren A. Marr8, Vicki A. Morrison9, M. Hong Nguyen10, Brahm H. Segal11, William J. Steinbach12, David A. Stevens13, Thomas J. Walsh14, John R. Wingard15, Jo-Anne H. Young9, John E. Bennett16+Dedication: The panel dedicates these guidelines to the memory of our dear friend Susan Hadley MD, a core member of the Mycoses Study Group, caring physician, and wonderful colleague.1The University of Texas Health Science Center at San Antonio and South Texas Veterans Health Care System, San Antonio, TX2Departments of Medicine/Division of Infectious Diseases and Medical Microbiology and Immunology, University of California, Davis, CA3National Aspergillosis Centre, University Hospital of South Manchester, University of Manchester, United Kingdom.4Massachusetts General Hospital and Harvard Medical School, Boston, MA.5Department of Medicine Tufts Medical Center Boston, MA.§ It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient’s individual circumstances.6Department of Oncology and Hematology, Hautepierre Hospital, University of Strasbourg, Strasbourg, France7Department of Infectious Diseases, Infection Control and Employee Health, The University of Texas M.D. Anderson Cancer Center, Houston, TX8Johns Hopkins University School of Medicine and the Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD9Department of Medicine/Division of Infectious Diseases, University of Minnesota, Minneapolis, MN 10Department of Medicine and Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA11Department of Medicine, School of Medicine and Biomedical Sciences, University at Buffalo, and Departments of Medicine and Immunology, Roswell Park Cancer Institute, Buffalo, NY12Department of Pediatrics/Division of Pediatric Infectious Diseases, Department of Molecular Genetics and Microbiology, Duke University Medical Center Durham, NC13 California Institute for Medical Research, San Jose, CA14Departments of Medicine, Pediatrics, and Microbiology and Immunology, New York-Presbyterian Hospital -Weill Cornell Medical Center, New York15Department of Medicine, University of Florida, Gainesville, FL16Laboratory of Clinical Infectious Diseases, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda, MDRunning head: IDSA guidelines for aspergillosis+Thomas F. Patterson and John E. Bennett served as co-chairs for the IDSA Aspergillus Guidelines Committee*Corresponding Author:Thomas F. Patterson, MD, FACP, FIDSADivision of Infectious DiseasesProfessor of MedicineDirector, San Antonio Center for Medical MycologyThe University of Texas Health Science Center at San Antonio 7703 Floyd Curl Drive -- MSC 7881San Antonio TX 78229-3900Email: patterson@uthscsa.eduEXECUTIVE SUMMARYBackgroundAspergillus species continue to be an important cause of life-threatening infection in immunocompromised patients. This at-risk population is comprised of patients with prolonged neutropenia, allogeneic hematopoietic stem cell transplantation (HSCT), solid-organ transplantation, inherited or acquired immunodeficiencies, corticosteroid use, and others. This document constitutes the Guidelines of the Infectious Diseases Society of America (IDSA) for treatment of aspergillosis and replaces the Practice Guidelines for Aspergillus published in 2008. Since that publication, clinical studies evaluating new and existing therapies including combination therapy for the management of Aspergillus infection have been conducted and the data on use of non-culture-based biomarkers for diagnosing infection has been expanded. The objective of these Guidelines is to summarize the current evidence for treatment of different forms of aspergillosis. This document reviews guidelines for management of the three major forms of aspergillosis: invasive aspergillosis (IA); chronic (and saprophytic) forms of aspergillosis; and allergic forms of aspergillosis. Given the clinical importance of IA, emphasis is placed upon the diagnosis, treatment, and prevention of the different forms of invasive aspergillosis, including invasive pulmonary aspergillosis (IPA), Aspergillus sinusitis, disseminated aspergillosis, and several types of single organ IA. Summarized below are the 2016 recommendations for the management of aspergillosis. Due to the guidelines relevance to pediatrics, the guideline has been reviewed and endorsed by the Pediatric Infectious Diseases Society (PIDS). The panel followed a guideline development process that has been adopted by IDSA, which includes use of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system, a systematic method of grading both the strength of the recommendation (weak or strong) and the quality of evidence (very low, low, moderate, and high) (Figure 1). The guidelines are not intended to replace clinical judgment in the management of individual patients. A detailed description of the methods, background, and evidence summaries that support each recommendation can be found in the full text of the guideline.EPIDEMIOLOGY AND RISK FACTORS FOR INFECTIONI. How can the most susceptible patients be protected from aspergillosis and which patients are most susceptible? What are sources of exposure to Aspergillus and how can exposure be decreased? Is environmental surveillance useful?Recommendations1.Hospitalized allogeneic HSCT recipients should be placed in a protected environment to reduce mould exposure (Strong Recommendation; Low Quality Evidence). 2.These precautions can be reasonably applied to other highly immunocompromised patients at increased risk for IA, such as patients receiving induction/re-induction regimens for acute leukemia (Strong Recommendation; Low Quality Evidence). 3.In hospitals in which a protected environment is not available, we recommend admission to a private room, no connection to construction sites, and not allowing plants or cut flowers to be brought into the patient’s room (Strong Recommendation; Low Quality Evidence:).4.We recommend reasonable precautions to reduce mould exposure among outpatients at high risk for IA, including avoidance of gardening, spreading mulch (compost) or close exposure to construction or renovation (Strong Recommendation; Low Quality Evidence). 5.Leukemia and transplant centers should perform regular surveillance of cases of invasive mould infection. An increase in incidence over baseline or the occurrence of invasive mould infections in patients who are not at high risk for such infections should prompt evaluation for a hospital source (Strong Recommendation; Low Quality Evidence). DIAGNOSIS OF ASPERGILLOSIS II. How can a diagnosis of IA be established?How should Aspergillus be identified and how does this influence management? Recommendation6.Until molecular tools are more widely used in clinical laboratories, we recommend that tissue and fluid specimens be submitted in adequate quantities for simultaneous histopathologic/cytologic and culture examination. In the case of isolates with atypical growth or concerns for resistance, species identification by molecular methods should be employed. (Strong Recommendation; High Quality Evidence).What is the diagnostic value of nucleic acid testing in clinical specimens?Recommendations7.There was debate among the committee members regarding the clinical utility of blood-based PCR in diagnosing IA and experts were not in agreement.? One group favored recommendations for PCR testing, based on publications validating its?role when used in conjunction with other tests such as antigen detection assays to diagnose IA and/or reduce pre-emptive antifungal usage.? The other group felt that PCR assays are promising, but could not be recommended for routine use in clinical practice at present due to the lack of conclusive validation for commercially available assays, the variety of?methodologies in the literature, and questions about the extent to which results assisted diagnosis.???8.As research in the area continues, we recommend that clinicians?choosing to?use PCR assays employ them carefully in the management of individual patients on a case-by-case basis.? Clinicians should be aware of the methodologies and performance?characteristics of the specific assay used, and interpret results accordingly.?When PCR assays are used, results should be considered in conjunction with other diagnostic tests and the clinical context (Strong Recommendation; Moderate Quality Evidence).?How should galactomannan (GM) and (1→3)-β-D-glucan be used for the diagnosis of aspergillosis? Recommendations9.Serum and BAL GM is recommended as an accurate marker for the diagnosis of IA in adult and pediatric patients when used in certain patient subpopulations (hematologic malignancy, HSCT) (Strong Recommendation; High Quality Evidence). 10.GM is not recommended for routine blood screening in patients receiving mould-active antifungal therapy or prophylaxis, but can be applied to bronchoscopy specimens from those patients (Strong Recommendation; High Quality Evidence). 11.GM is not recommended for screening in solid organ transplant recipients or patients with chronic granulomatous disease (CGD) (Strong Recommendation; High Quality Evidence). 12.Serum assays for (1→3)-β-D-glucan are recommended for diagnosing IA in high risk patients (hematologic malignancy, allogeneic HSCT), but are not specific for Aspergillus (Strong Recommendation; Moderate Quality Evidence).What is the approach to the radiographic diagnosis of IPA?Recommendations13.We recommend performing a chest computed tomographic (CT) scan whenever there is a clinical suspicion for IPA regardless of chest radiograph results (Strong Recommendation; High Quality Evidence). 14.Routine use of contrast during a chest CT scan for a suspicion of IPA is not recommended (Strong Recommendation; Moderate Quality Evidence). Contrast is recommended when a nodule or a mass is close to a large vessel (Strong Recommendation; Moderate Quality Evidence). 15.We suggest a follow-up chest CT-scan to assess the response of IPA to treatment after a minimum of two weeks of treatment; earlier assessment is indicated if the patient clinically deteriorates (Weak Recommendation; Low Quality Evidence). When a nodule is close to a large vessel, more frequent monitoring may be required (Weak Recommendation; Low Quality Evidence).What is the role of bronchoscopy in the diagnosis of IPA? Recommendation16.We recommend performing a bronchoscopy with bronchoalveolar lavage (BAL) in patients with a suspicion of IPA (Strong Recommendation; Moderate Quality Evidence) Significant comorbidities such as severe hypoxemia, bleeding, and platelet transfusion-refractory thrombocytopenia may preclude BAL. The yield of BAL is low for peripheral nodular lesions, so that percutaneous or endobronchial lung biopsy should be considered. We recommend the use of a standardized BAL procedure and sending the BAL sample for routine culture and cytology as well as non-culture-based methods (e.g. GM) (Strong Recommendation; Moderate Quality Evidence). III. What antifungal agents are available for the treatment and prophylaxis of IA including pharmacologic considerations and what is the role for susceptibility testing? Amphotericin B (AmB)Recommendations17.AmB deoxycholate and its lipid derivatives are appropriate options for initial and salvage therapy of Aspergillus infections when voriconazole cannot be administered. However, AmB deoxycholate should be reserved for use in resource-limited settings in which no alternative agents are available. Lipid formulations of AmB should be considered in settings in which azoles are contraindicated or not tolerated (Strong Recommendation; Moderate Quality Evidence).18.Aerosolized formulations of AmB may be considered as prophylaxis in patients with prolonged neutropenia (patients receiving induction/re-induction therapy for acute leukemia and allogeneic HSCT recipients following conditioning or during treatment of Graft versus Host Disease [GVHD]) and in lung transplant recipients (Weak Recommendation; Low Quality Evidence).EchinocandinsRecommendation19.Echinocandins are effective in salvage therapy (either alone or in combination) against IA, but we do not recommend their routine use as monotherapy for the primary treatment of IA (Strong Recommendation; Moderate Quality Evidence). TriazolesRecommendations20.Triazoles are preferred agents for treatment and prevention of IA in most patients (Strong Recommendation; High Quality Evidence). 21.For patients receiving triazole-based therapy for IA, prolonged azole prophylaxis, or other therapies for which drug interactions with azoles are anticipated, the committee recommends therapeutic drug monitoring (TDM) once the steady state has been reached. A moderate amount of data for itraconazole, voriconazole, and posaconazole suspension suggests this approach may be valuable in enhancing therapeutic efficacy, in evaluating therapeutic failures attributable to suboptimal drug exposures, and to minimize toxicities potentially attributable to the azoles. (Strong Recommendation; Moderate Quality Evidence). Further studies are needed to address whether TDM is helpful or necessary with the extended release or intravenous formulations of posaconazole or for isavuconazole.22.Clinicians should obtain serum trough drug levels for azole antifungal agents (itraconazole, voriconazole, posaconazole, and possibly isavuconazole) and for potentially interacting drugs such as cyclosporine, tacrolimus, and sirolimus (and other CYP450 3A4 substrates such as tyrosine kinase inhibitors) to optimize therapeutic efficacy and to avoid potential toxicities of both groups of agents (Strong Recommendation; Moderate Quality Evidence). Preclinical and Laboratory Assessment of Combination antifungal binations of polyenes or azoles with echinocandins suggest additive or synergistic effects in some pre-clinical studies.? However, variable test designs and conflicting results of preclinical and in vitro testing have led to uncertainty as to how to interpret the findings.? (Weak Recommendation; Low Quality Evidence).When should antifungal susceptibility testing be performed and how should results be interpreted and affect management?Recommendation24.Routine antifungal susceptibility testing of isolates recovered during initial infection is not recommended. Antifungal susceptibility testing of Aspergillus isolates using a reference method is reserved for patients suspected to have an azole resistant isolate, who are unresponsive to antifungal agents, or for epidemiological purposes (Strong Recommendation; Moderate Quality Evidence).INVASIVE SYNDROMES OF ASPERGILLUSIV. What are the recommended treatment regimens and adjunctive treatment measures for the various clinical presentation of IA?How should IPA be treated?Recommendations25.We recommend primary treatment with voriconazole (Strong Recommendation; High Quality Evidence). 26.Early initiation of antifungal therapy in patients with strongly suspected IPA is warranted while a diagnostic evaluation is conducted (Strong Recommendation; High Quality Evidence)27.Alternative therapies include liposomal AmB (Strong Recommendation; Moderate Quality Evidence), isavuconazole (Strong Recommendation; Moderate Quality Evidence), or other lipid formulations of AmB (Weak Recommendation; Low Quality Evidence). bination antifungal therapy with voriconazole and an echinocandin may be considered in select patients with documented IPA (Weak Recommendation; Moderate Quality Evidence).29.Primary therapy with an echinocandin is not recommended (Strong Recommendation; Moderate Quality Evidence). Echinocandins (micafungin or caspofungin) can be used in settings in which azole and polyene antifungals are contraindicated (Weak Recommendation; Moderate Quality Evidence).30.We recommend that treatment of IPA be continued for a minimum of 6-12 weeks, largely dependent on the degree and duration of immunosuppression, site of disease, and evidence of disease improvement (Strong Recommendation; Low Quality Evidence). 31.For patients with successfully treated IPA who require subsequent immunosuppression, secondary prophylaxis should be initiated to prevent recurrence (Strong Recommendation; Moderate Quality Evidence). Adjunctive measures and immunomodulation: When should withdrawal of immunosuppressive agents, or addition of colony stimulating factors (CSFs) or granulocyte transfusions be considered in the treatment of IA?Recommendations32.Reducing doses of, or eliminating altogether, immunosuppressive agents, when feasible, is advised as a component of anti-Aspergillus therapy (Strong Recommendation; Low Quality Evidence).33.Colony stimulating factors may be considered in neutropenic patients with diagnosed or suspected IA (Weak Recommendation; Low Quality Evidence). There is insufficient evidence regarding the value of G-CSF versus GM-CSF in this setting.34.Granulocyte transfusions can be considered for neutropenic patients with IA that is refractory or are unlikely to respond to standard therapy, and for an anticipated duration of more than one week (Weak Recommendation; Low Quality Evidence). 35.Recombinant interferon- is recommended as prophylaxis in CGD patients (Strong Recommendation; High Quality Evidence). Its benefit as adjunctive therapy for IA is unknown.36.Surgery for aspergillosis should be considered for localized disease that is easily accessible to debridement (e.g., invasive fungal sinusitis or localized cutaneous disease) (Strong Recommendation; Low Quality Evidence). The benefit for IA in other settings such as in the treatment of endocarditis, osteomyelitis or focal central nervous system (CNS) disease appears rational. Other indications are less clear and require consideration of the patient’s immune status, co-morbidities, confirmation of a single focus, and the risks of surgery.When is it safe to proceed with chemotherapy or transplantation in a patient with IA?Recommendations37.IA is not an absolute contraindication to additional chemotherapy or HSCT (Strong Recommendation; Moderate Quality Evidence).38.Decisions about when to proceed with additional chemotherapy or HSCT following the diagnosis of aspergillosis should involve both Infectious Diseases specialists and Hematologists/Oncologists. These decisions must consider the risk of progressive aspergillosis during periods of subsequent anti-neoplastic treatment versus the risk of death from the underlying malignancy if this treatment is delayed (Strong Recommendation; Low Quality Evidence).What approaches are needed for refractory or progressive aspergillosis (salvage therapy)?Recommendations39.We recommend an individualized approach that takes into consideration the rapidity, severity, extent of infection, patient co-morbidities, and to exclude the emergence of a new pathogen (Strong Recommendation; Low Quality Evidence). The general strategies for salvage therapy typically include, (i) changing the class of antifungal; (ii) tapering or reversal of underlying immunosuppression when feasible, and (iii) surgical resection of necrotic lesions in selected cases.40. In the context of salvage therapy, an additional antifungal agent may be added to current therapy, or combination antifungal drugs from different classes other than those in the initial regimen may be used (Weak Recommendation; Moderate Quality Evidence).41.In patients currently receiving an antifungal and exhibiting an adverse event attributable to this agent, we recommend changing to an alternative class of antifungal, or the use of an alternative agent with a non-overlapping side-effect profile (Strong Recommendation; Low Quality Evidence).42.For salvage therapy, agents include lipid formulations of AmB, micafungin, caspofungin, posaconazole or itraconazole. The use of a triazole as salvage therapy should take into account prior antifungal therapy, host factors, pharmacokinetic considerations, and possible antifungal resistance (Strong Recommendation; Moderate Quality Evidence).How can biomarkers be used to assess patient response to therapy?Recommendations43.Serial monitoring of serum GM can be used in the appropriate patient subpopulations (hematologic malignancy, HSCT) who have an elevated GM at baseline to monitor disease progression, therapeutic response, and predict outcome (Strong Recommendation; Moderate Quality Evidence). 44.(1→3)-β-D-glucan has not been extensively studied in IA to predict outcome (Weak Recommendation; Low Quality Evidence).What are the recommended treatments for pediatric patients with aspergillosis?Recommendation45.Treatment of aspergillosis in children uses the same recommended therapies as in adult patients, however the dosing is different and for some antifungals is unknown (Strong Recommendation; High Quality Evidence).What are treatment options for aspergillosis of the airways in transplant and nontransplant recipients and how does it differ from IPA?Recommendations46.Saprophytic forms of tracheobronchial aspergillosis (TBA) do not require antifungal treatment except for symptomatic or immunosuppressed patients. Treatment includes bronchoscopic removal of mucoid impaction. Mould-active triazole agents are recommended for immunocompromised patients in whom the possibility of invasive disease cannot be eliminated (Strong Recommendation; Moderate Quality Evidence) 47.Bronchocentric granulomatosis is treated in the same fashion as allergic bronchopulmonary aspergillosis (ABPA) (Strong Recommendation; Low Quality Evidence). 48.Invasive forms of TBA are treated with a mould-active triazole or intravenous lipid formulations of AmB (Strong Recommendation; Moderate Quality Evidence). We also recommend minimization or reversal of underlying immunosuppression when feasible, and bronchoscopic debridement of airway lesions in selected cases (Strong Recommendation; Low Quality Evidence).49.In lung transplant recipients, we recommend treatment with a systemic anti-mould antifungal for TBA, including saprophytic forms. We also recommend adjunctive inhaled AmB in the setting of TBA associated with anastomotic endobronchial ischemia or ischemic reperfusion injury due to airway ischemia associated with lung transplantation (Strong Recommendation; Moderate Quality Evidence). Duration of antifungal therapy is at least 3 months or until TBA is completely resolved, whichever is longer. MANAGEMENT OF EXTRAPULMONARY ASPERGILLOSISWhat are the treatment considerations for CNS aspergillosis?Recommendation50.We recommend voriconazole as primary therapy for CNS aspergillosis (Strong Recommendation; Moderate Quality Evidence). Lipid formulations of AmB are reserved for those intolerant or refractory to voriconazole (Strong Recommendation; Moderate Quality Evidence).How is Aspergillus endophthalmitis treated?Recommendation51.We recommend that Aspergillus endophthalmitis be treated with systemic oral or intravenous voriconazole plus intravitreal voriconazole or intravitreal AmB deoxycholate (Strong Recommendation; Weak Quality Evidence).What is the role of surgery in aspergillosis of the paranasal sinuses?Recommendation52.We recommend that both surgery and either systemic voriconazole or a lipid formulation of AmB be used in invasive Aspergillus fungal sinusitis but that surgical removal alone can be used to treat Aspergillus fungal ball of the paranasal sinus. Enlargement of the sinus ostomy may be needed to improve drainage and prevent recurrence (Strong Recommendation; Moderate Quality Evidence). What are the treatment recommendations for Aspergillus endocarditis, pericarditis, and myocarditis?Recommendation53.In Aspergillus endocarditis, we recommend early surgical intervention combined with antifungal therapy in attempts to prevent embolic complications and valvular decompensation (Strong Recommendation; Moderate Quality Evidence). Voriconazole or a lipid formulation of AmB is recommended as initial therapy (Strong Recommendation; Low Quality Evidence). Following surgical replacement of an infected valve, lifelong antifungal therapy should be considered (Strong Recommendation; Low Quality Evidence).What are the treatment recommendations for Aspergillus osteomyelitis and septic arthritis?Recommendation54.Surgical intervention is recommended, where feasible, for management of Aspergillus osteomyelitis and arthritis, combined with voriconazole (Strong Recommendation; Moderate Quality Evidence).What are the treatment recommendations for cutaneous aspergillosis? Recommendations55.As cutaneous lesions may reflect disseminated infection, we recommend treatment with voriconazole in addition to evaluation for a primary focus of infection (Strong Recommendation; Low Quality Evidence). 56.In cases of aspergillosis in burns or massive soft tissue wounds, surgical debridement is recommended, in addition to antifungal therapy (Strong Recommendation; Moderate Quality Evidence). What are the treatment recommendations for Aspergillus peritonitis?Recommendation57.We recommend prompt peritoneal dialysis catheter removal accompanied by systemic antifungal therapy with voriconazole (Strong Recommendation; Weak Quality Evidence). What are the treatment recommendations for esophageal, gastrointestinal, and hepatic aspergillosis?Recommendations58.We suggest voriconazole and surgical consultation in attempts to prevent complications of hemorrhage, perforation, obstruction or infarction (Weak Recommendation; Low Quality Evidence). 59.We suggest antifungal therapy with voriconazole or a lipid formulation of AmB as initial therapy for hepatic aspergillosis. For extrahepatic or perihepatic biliary obstruction, or localized lesions that are refractory to medical therapy, surgical intervention is should be considered (Weak Recommendation; Low Quality Evidence). What are the treatment recommendations for renal aspergillosis?Recommendation60.We suggest a combined approach of medical and urologic management for renal aspergillosis. Obstruction of one or both ureters should be managed with decompression if possible and local instillation of AmB deoxycholate. Parenchymal disease is best treated with voriconazole (Weak Recommendation; Low Quality Evidence).What are the treatment regimens for Aspergillus ear infections?Recommendations61.Noninvasive Aspergillus otitis externa, also called otomycosis, is treated by thorough mechanical cleansing of the external auditory canal followed by topical antifungals or boric acid (Strong Recommendation; Moderate Quality Evidence).62.We recommend that clinicians treat IA of the ear with a prolonged course of systemic voriconazole, usually combined with surgery (Strong Recommendation; Low Quality Evidence). What are the treatment recommendations for Aspergillus keratitis?Recommendation63.We recommend that clinicians treat Aspergillus keratitis with topical natamycin 5% ophthalmic suspension or topical voriconazole (Strong Recommendation; Moderate Quality Evidence).How should Aspergillus bronchitis be diagnosed and treated in the non-transplant population?Recommendations64.We suggest the diagnosis of aspergillus bronchitis in non-transplant patients be confirmed by detection of Aspergillus spp. in respiratory secretions, usually sputum, with both PCR and GM on respiratory samples being much more sensitive than culture (Weak Recommendation; Low Quality Evidence).65.??? We suggest treatment with oral itraconazole or voriconazole with therapeutic drug monitoring (Weak Recommendation; Low Quality Evidence).V. What are the recommended prophylactic regimens: who should receive them and how should breakthrough infection be managed?PROPHYLAXIS OF IAIn what patients should antifungal prophylaxis against aspergillosis be used? Recommendation66.We recommend prophylaxis with posaconazole (Strong Recommendation; High Quality Evidence), voriconazole (Strong Recommendation; Moderate Quality Evidence), and/or micafungin (Weak Recommendation; Low Quality Evidence) during prolonged neutropenia for those who are at high risk for IA (Strong Recommendation; High Quality Evidence). Prophylaxis with caspofungin is also probably effective (Weak Recommendation; Low Quality Evidence). Prophylaxis with itraconazole is effective, but therapy may be limited by absorption and tolerability (Strong Recommendation; Moderate Quality Evidence). Triazoles should not be co-administered with other agents known to have potentially toxic levels with concurrent triazole coadministration (such as vinca alkaloids, and others) (Strong Recommendation; Moderate Quality Evidence).What are the recommended prophylactic regimens for patients with GVHD? Recommendations67.We recommend prophylaxis with posaconazole for allogeneic HSCT recipients with GVHD who are at high risk for IA (Strong Recommendation; High Quality Evidence). Prophylaxis with other mould-active azoles is also effective. Voriconazole is commonly used for prophylaxis against IA in high risk patients but did not show improved survival in clinical trials (Strong Recommendation; Moderate Quality Evidence). Prophylaxis with itraconazole is limited by tolerability and absorption (Strong Recommendation; High Quality Evidence). 68.We recommend continuation of antifungal prophylaxis throughout the duration of immunosuppression in patients with chronic immunosuppression associated with GVHD (corticosteroid equivalent of >1 mg/kg/day of prednisone for >2 weeks and/or the use of other anti-GVHD therapies, such as lymphocyte depleting agents, or tumor necrosis factor α (TNF-α) inhibition, for refractory GVHD) (Strong Recommendation; High Quality Evidence).What are the recommendations for antifungal prophylaxis in lung transplant patients?Recommendations69.We recommend antifungal prophylaxis with either a systemic triazole such as voriconazole or itraconazole or an inhaled AmB product for 3 to 4 months after lung transplant (Strong Recommendation; Moderate Quality Evidence).70.Systemic voriconazole or itraconazole is suggested over inhaled amphotericin B for lung transplant recipients with mould colonization pre- or post- lung transplantation, mould infections found in explanted lungs, fungal infections in the sinus, and single lung transplant recipients. (Weak Recommendation; Low Quality Evidence).71.We recommend reinitiating antifungal prophylaxis for lung transplant recipients receiving immunosuppression augmentation with either thymoglobulin, alemtuzumab, or high dose corticosteroids (Strong Recommendation; Moderate Quality Evidence).What are the recommendations for antifungal prophylaxis in non-lung solid organ transplant recipients?Recommendation72.We recommend prophylactic strategies in solid organ transplant recipients based on the institutional epidemiology of infection and assessment of individual risk factors (Strong Recommendation; Low Quality Evidence).? Prospective trials are lacking to address the need for routine anti-Aspergillus prophylaxis other than for lung transplant recipients.? Individual risk factors have been identified in cardiac (pre-transplant colonization, reoperation, cytomegalovirus (CMV) infection, renal dysfunction, institutional outbreak), liver (fulminant hepatic failure, reoperation, retransplantation or renal failure), and others with institutional outbreaks or prolonged or high-dose corticosteroid use.? In such patients, the optimal duration of prophylaxis is not known.? MANAGEMENT OF BREAKTHROUGH INFECTION How should breakthrough aspergillosis be managed?Recommendation73.We suggest an individualized approach that takes into consideration the rapidity and severity of infection and local epidemiology. As principles, we recommend an aggressive and prompt attempt to establish a specific diagnosis with bronchoscopy and/or CT-guided biopsy for peripheral lung lesions. Documentation of serum azole levels should be verified if TDM is available for patients receiving mould-active triazoles. Antifungal therapy should be empirically changed to an alternative class of antifungal with Aspergillus activity. Other considerations include reduction of underlying immunosuppression if feasible, and susceptibility testing of any Aspergillus isolates recovered from the patient (Weak Recommendation; Moderate Quality Evidence).VI. When should patients be treated empirically?What strategies are recommended for empirical and pre-emptive strategies in allogeneic HSCT recipients and patients treated for acute myelogenous leukemia (AML)? Recommendations74.Empirical antifungal therapy is recommended for high-risk patients with prolonged neutropenia who remain persistently febrile despite broad-spectrum antibiotic therapy. Antifungal options include a lipid formulation of AmB (Strong Recommendation; High Quality Evidence), an echinocandin (caspofungin or micafungin) (Strong Recommendation; High Quality Evidence), or voriconazole (Strong Recommendation; Moderate Quality Evidence). 75.Empirical antifungal therapy is not recommended for patients who are anticipated to have short durations of neutropenia (duration of neutropenia <10 days), unless other findings indicate a suspected invasive fungal infection (Strong Recommendation; Moderate Quality Evidence).76.The use of serum or BAL fungal biomarkers such as GM or (1→3)-β-D-glucan to guide antifungal therapy in asymptomatic or febrile high risk patients (often referred to as pre-emptive or biomarker-driven antifungal therapy) can reduce unnecessary antifungal therapy. The pre-emptive approach can result in more documented cases of invasive aspergillosis without compromise in survival and can be used as an alternative to empirical antifungal therapy (Strong Recommendation; Moderate Quality Evidence).77.Early initiation of antifungal therapy in patients with strongly suspected IPA is warranted while a diagnostic evaluation is conducted (Strong Recommendation; Moderate Quality Evidence). 78.Management of suspected or documented breakthrough IPA in the context of mould-active azole prophylaxis or empirical suppressive therapy is not defined by clinical trial data but a switch to another drug class is suggested (Weak Recommendation; Low Quality Evidence). How do lung transplant recipients differ from other immunosuppressed patients in management of suspected IPA?Recommendations79.In lung transplant recipients not on anti-mould prophylaxis, we suggest pre-emptive therapy with an anti-mould antifungal for asymptomatic patients with Aspergillus colonization of the airways within 6 months of lung transplantation or within 3 months of receiving immunosuppression augmentation for rejection (Weak Recommendation; Moderate Quality Evidence).80.Six months after lung transplantation and in the absence of recent immunosuppression augmentation for rejection, it may be prudent to withhold antifungal therapy for Aspergillus airway colonization (i.e., Aspergillus respiratory cultures in the absence of clinical features that suggest disease, such as compatible symptoms, or bronchoscopic, histopathologic and/or radiographic findings) (Weak Recommendation; Low Quality Evidence).CHRONIC AND SAPROPHYTIC SYNDROMES OF ASPERGILLUSVII. How should chronic aspergillosis, allergic or non-invasive syndromes be managed?How can chronic cavitary pulmonary aspergillosis (CCPA) be diagnosed and treated?Recommendations81.??The diagnosis of CCPA requires: (1) 3 months of chronic pulmonary symptoms or chronic illness or progressive radiographic abnormalities, with cavitation, pleural thickening, peri-cavitary infiltrates and sometimes a fungal ball; (2) Aspergillus IgG antibody elevated or other microbiological data; and (3) no or minimal immunocompromise, usually with one or more underlying pulmonary disorders. The Aspergillus IgG antibody test is the most sensitive microbiological test (Strong Recommendation; Moderate Quality Evidence). Sputum Aspergillus PCR testing is more sensitive than culture (Weak Recommendation; Moderate Quality Evidence).82.Patients with CCPA without pulmonary symptoms, weight loss or significant fatigue, and those without major impairment of pulmonary function or gradual loss of pulmonary function may be observed without antifungal therapy and followed every 3-6 months (Weak Recommendation; Low Quality Evidence).83. Patients with CCPA and either pulmonary or general symptoms or progressive loss of lung function or radiographic progression should be treated with a minimum of 6 months of antifungal therapy (Strong Recommendation; Low Quality Evidence).84. Oral itraconazole and voriconazole are the preferred oral antifungal agents (Strong Recommendation; High Quality Evidence); posaconazole is a useful third-line agent for those with adverse events or clinical failure (Strong Recommendation; Moderate Quality Evidence).85.Hemoptysis may be managed with oral tranexamic acid (Weak Recommendation; Low Quality Evidence), bronchial artery embolization (Strong Recommendation; Moderate Quality Evidence) or antifungal therapy to prevent recurrence (Strong Recommendation; Low Quality Evidence). Patients failing these measures may require surgical resection (Weak Recommendation; Moderate Quality Evidence). 86.In those who fail therapy, who develop triazole resistance and/or have adverse events, intravenous micafungin (Weak Recommendation; Low Quality Evidence), caspofungin (Weak Recommendation; Low Quality Evidence), or amphotericin B (Weak Recommendation; Low Quality Evidence) yield some responses. Treatment may need to be prolonged.87.Surgical resection is an option for some patients with localized disease, unresponsive to medical therapy, including those with pan-azole resistant A. fumigatus infection or persistent hemoptysis despite bronchial artery embolization (Strong Recommendation; Moderate Quality Evidence). The outcomes from surgery are less favorable than those with single aspergilloma, and a careful risk assessment prior to surgical intervention is required. 88.In those with progressive disease, long term, even life-long antifungal therapy may be required to control disease (Weak Recommendation; Low Quality Evidence), with continual monitoring for toxicity and resistance.What are the management options for an Aspergillus fungal ball of the lung (aspergilloma)?Recommendations89.Asymptomatic patients with a single aspergilloma and no progression of the cavity size over 6-24 months should continue to be observed (Strong Recommendation; Moderate Quality Evidence).90.Patients with symptoms, especially significant hemoptysis, with a single aspergilloma, should have it resected, assuming that there are no contraindications (Strong Recommendation; Moderate Quality Evidence).91.Peri/post-operative antifungal therapy is not routinely required, but if the risk of surgical spillage of the aspergilloma is moderate (related to location and morphology of the cavity) antifungal therapy with voriconazole (or another mould active azole) or an echinocandin is suggested to prevent Aspergillus empyema (Weak Recommendation; Low Quality Evidence). ALLERGIC SYNDROMES OF ASPERGILLUSHow is ABPA identified and managed, in patients with asthma and cystic fibrosis (CF)?Recommendations92.Elevated Aspergillus IgE and total IgE are recommended to establish the diagnosis and are useful for screening (Strong Recommendation; High Quality Evidence).93.We suggest treating symptomatic asthmatic patients with bronchiectasis or mucoid impaction, despite oral or inhaled corticosteroid therapy, with oral itraconazole therapy with therapeutic drug monitoring (Weak Recommendation; Low Quality Evidence).94.In CF patients with frequent exacerbations and/or falling FEV1, we suggest treating with oral itraconazole to minimize corticosteroid use with therapeutic drug monitoring, and consideration of other mould-active azole therapy if therapeutic levels cannot be achieved. (Weak Recommendation; Low Quality Evidence).What is the medical management of allergic fungal rhinosinusitis caused by Aspergillus spp.?Recommendations95.We recommend establishing the diagnosis of allergic fungal rhinosinusitis (AFRS) in patients with nasal polyposis and thick eosinophilic mucin by visualizing hyphae in mucus, which is supported by a positive anti-Aspergillus IgE serum antibody assay or skin prick test (where available) (Strong Recommendation; Moderate Quality Evidence). 96.We recommend polypectomy and sinus washout as the optimal means of symptom control and inducing remission, however relapse is frequent (Strong Recommendation; Moderate Quality Evidence).97.We recommend the use of topical nasal steroids to reduce symptoms and increase time to relapse, especially if given after surgery (Strong Recommendation; Moderate Quality Evidence).98.We suggest oral antifungal therapy using mould-active triazoles for refractory infection and/or rapidly relapsing disease, although this approach is only partially effective (Weak Recommendation; Low Quality Evidence).INTRODUCTIONIA remains a major cause of morbidity and mortality in high risk immunocompromised patients. Additionally, chronic and allergic syndromes due to Aspergillus are recognized to affect an even greater number of additional patients. In recent years, the clinical evidence for the diagnosis and management of patients with Aspergillus syndromes has vastly increased. New agents and formulations along with studies for the use of older agents are available for treating patients with these infections, and new diagnostic tools have increased the ability to diagnose these infections in a timely manner. This document constitutes the Guidelines of the Infectious Diseases Society of America (IDSA) for treatment of aspergillosis. These guidelines replace the Practice Guidelines for Aspergillus published in 2008 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWxzaDwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [1] and incorporate new clinical evidence in the recommendations. The objective of these Guidelines is to summarize the current evidence for treatment of different forms of aspergillosis. The panel followed the GRADE framework as adopted by the IDSA. In the recommendation section which follows, the panel answered a series of broad questions for managing syndromes of aspergillosis and the background and evidence for the recommendations are presented: I. How can the most susceptible patients be protected from aspergillosis and which patients are most susceptible? II. How can a diagnosis of IA be established?III. What antifungal agents are available for the treatment and prophylaxis of IA including pharmacologic considerations and role for susceptibility testing?IV. What are the recommended treatment regimens and adjunctive treatment measures for the various clinical presentations of IA?V. What are the recommended prophylactic regimens: who should receive them and how should breakthrough infection be managed?VI. When should patients be treated empirically?VII. How should chronic aspergillosis, allergic or non-invasive syndromes be managed?METHODOLOGYPanel CompositionThe most recent version of the IDSA guidelines on the management of patients with aspergillosis was published in 2008 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWxzaDwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [1]. For this update, the IDSA Standards and Practice Guidelines Committee convened a multidisciplinary panel of 17 experts in the management of patients with aspergillosis. The panel consisted of 17 members of the IDSA, and included 16 adult infectious diseases physicians and 1 pediatric infectious diseases physician. All panel members were selected on the basis of their expertise in clinical and/or laboratory mycology with a focus on aspergillosis.Evidence Review - The GRADE Method GRADE is a systematic approach to guideline development that has been described in detail elsewhere PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HdXlhdHQ8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [2, 3]. The IDSA/HIV Medicine Association (HIVMA) adopted GRADE in 2008. In the GRADE system, the guideline panel assigns each recommendation with separate ratings for the underlying quality of evidence supporting the recommendation and for the strength with which the recommendation is made (Figure 1) ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1" ExcludeYear="1"><RecNum>1113</RecNum><DisplayText>[4]</DisplayText><record><rec-number>1113</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1461689151">1113</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>U.S. GRADE Network. Approach and implications to rating the quality of evidence and strength of recommendations using the GRADE methodology. Available at: . Accessed April, 2016</title></titles><dates></dates><urls></urls></record></Cite></EndNote>[4]. Data from randomized controlled trials begin as “high” quality, and data from observational studies begin as “low” quality. However, the panel may judge that specific features of the data warrant decreasing or increasing the quality of evidence rating, and GRADE provides guidance on how such factors should be weighed ADDIN EN.CITE <EndNote><Cite><Author>Guyatt</Author><Year>2011</Year><RecNum>178</RecNum><DisplayText>[3]</DisplayText><record><rec-number>178</rec-number><foreign-keys><key app="EN" db-id="teffsv9psevveiedfz35tttlf9tz5es2dwtp">178</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Guyatt, G. H.</author><author>Oxman, A. D.</author><author>Schunemann, H. J.</author><author>Tugwell, P.</author><author>Knottnerus, A.</author></authors></contributors><auth-address>Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario L8N 3Z5, Canada. guyatt@mcmaster.ca</auth-address><titles><title>GRADE guidelines: a new series of articles in the Journal of Clinical Epidemiology</title><secondary-title>Journal of clinical epidemiology</secondary-title><alt-title>J Clin Epidemiol</alt-title></titles><periodical><full-title>Journal of clinical epidemiology</full-title><abbr-1>J Clin Epidemiol</abbr-1></periodical><alt-periodical><full-title>Journal of clinical epidemiology</full-title><abbr-1>J Clin Epidemiol</abbr-1></alt-periodical><pages>380-2</pages><volume>64</volume><number>4</number><edition>2010/12/28</edition><keywords><keyword>Evidence-Based Medicine/*standards</keyword><keyword>Guideline Adherence</keyword><keyword>Humans</keyword><keyword>Periodicals as Topic/standards</keyword><keyword>Practice Guidelines as Topic/standards</keyword><keyword>Publication Bias</keyword><keyword>Quality Assurance, Health Care/*standards</keyword></keywords><dates><year>2011</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1878-5921 (Electronic)&#xD;0895-4356 (Linking)</isbn><accession-num>21185693</accession-num><urls><related-urls><url>;[3]. The strength assigned to a recommendation reflects the panel’s confidence that the benefits of following the recommendation are likely to outweigh potential harms. While the quality of evidence is an important factor in choosing recommendation strength, it is not prescriptive. Process Overview Panel members were each assigned to review the recent literature for at least one topic, evaluate the evidence, determine the strength of recommendations and develop written evidence in support of these recommendations. The panel met face-to-face once and conducted a series of conference calls over a 10-month period. The panel reviewed and discussed all recommendations, their strength, and the quality of evidence. Discrepancies were discussed and resolved, and all final recommendations represent a consensus opinion of the entire panel. For the final version of these guidelines, the panel as a group reviewed all individual sections. Panel subgroups generated a list of keywords that were used by librarians at the Health Sciences Library—University of Pittsburg (with grateful acknowledgement to Michele Klein-Fedyshin and Charles B. Wessel) to develop PICO (population, intervention, comparison, outcomes) search strings for use in PubMed and results were returned to each primary author and the chairs for review. Searches were restricted to English language publications and covered the period of January, 2008 (when the last guideline was published) through December, 2014. Abstracts presented at international conferences within the past two years were also reviewed for inclusion. Systematic reviews of relevant topics were identified using PubMed and the Cochrane library. Each primary topic author was responsible for reviewing the literature relevant to their section, and drafting recommendations and evidence summaries for review and discussion by the full panel.Conflicts of InterestsThe expert panel complied with the IDSA policy on conflicts of interest, which requires disclosure of any financial or other interest that may be construed as constituting an actual, potential, or apparent conflict. Panel members were provided IDSA's conflicts of interest disclosure statement and were asked to identify ties to companies developing products that may be affected by promulgation of the guideline. Information was requested regarding employment, consultancies, stock ownership, honoraria, research funding, expert testimony, and membership on company advisory committees. Decisions were made on a case-by-case basis as to whether an individual's role should be limited as a result of a conflict. Potential conflicts of interests are listed in the Acknowledgments section. Review and Approval Process The panel obtained feedback from two external peer reviewers. The guidelines were reviewed and endorsed by the Pediatric Infectious Diseases Society (PIDS). The guideline was reviewed and approved by the IDSA Standards and Practice Guidelines Committee and the IDSA Board of Directors prior to dissemination.Future Guideline RevisionsAt annual intervals, the panel chairs will be asked for their input on the need to update the guideline based on an examination of the current literature. The Standards and Practice Guidelines Committee of the IDSA will consider this input and determine the necessity and timing of an update. If warranted, the entire panel or a subset thereof will be convened to discuss potential changes. EPIDEMIOLOGY AND RISK FACTORS FOR INFECTIONI. How can the most susceptible patients be protected from aspergillosis and which patients are most susceptible? What are sources of exposure to Aspergillus and how can exposure be decreased? Is environmental surveillance useful?Recommendations1.Hospitalized allogeneic HSCT recipients should be placed in a protected environment to reduce mould exposure (Strong Recommendation; Low Quality Evidence). 2.These precautions can be reasonably applied to other highly immunocompromised patients at increased risk for IA, such as patients receiving induction/re-induction regimens for acute leukemia (Strong Recommendation; Low Quality Evidence). 3.In hospitals in which a protected environment is not available, we recommend admission to a private room, no connection to construction sites, and not allowing plants or cut flowers to be brought into the patient’s room (Strong Recommendation; Low Quality Evidence).4.We recommend reasonable precautions to reduce mould exposure among outpatients at high risk for IA, including avoidance of gardening, spreading mulch (compost) or close exposure to construction or renovation (Strong Recommendation; Low Quality Evidence). 5.Leukemia and transplant centers should perform regular surveillance of cases of invasive mould infection. An increase in incidence over baseline or the occurrence of invasive mould infections in patients who are not at high risk for such infections should prompt evaluation for a hospital source (Strong Recommendation; Low Quality Evidence). Evidence summaryAspergillus species and other filamentous fungi are ubiquitous in the environment. The risks of exposure vary both temporally and geographically and are dependent on precipitation patterns, humidity, temperature, and wind conditions PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYW5hY2thbDwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+

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ADDIN EN.CITE.DATA [8-11]. Contamination of water systems has also been considered a source of nosocomial aspergillosis and other mould infections PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbmFpc3NpZTwvQXV0aG9yPjxZZWFyPjIwMDI8L1llYXI+

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ADDIN EN.CITE.DATA [12-17].Since there are numerous sources of mould in the environment, reasonable efforts should be made to decrease exposure to fungal spores in highly immunocompromised patients. Detailed guidelines have been published regarding hospital room design and ventilation to reduce mould exposure among allogeneic HSCT recipients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ub21ibHluPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48

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ADDIN EN.CITE.DATA [18]. A “protected environment” is recommended, which includes high efficiency particulate air (HEPA) filtration (and/or laminar airflow), maintenance of positive pressure rooms, and a minimum number of air exchanges per hour. Other at risk groups such as solid organ transplant and burn patients are often also placed in HEPA filtered rooms. Additional guidelines are provided to minimize mould exposure during hospital construction, renovation, and building PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXJ0cmlkZ2UtSGluY2tsZXk8L0F1dGhvcj48WWVhcj4y

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ADDIN EN.CITE.DATA [19]. These guidelines can reasonably be applied to other highly immunocompromised patients, such as those receiving induction/re-induction chemotherapy for acute leukemia. We are in agreement with these guidelines, but note that they are consensus criteria rather than evidence-based. We recognize that highly immunocompromised patients may be admitted to hospitals that lack the engineering standards providing for a “protected environment”. In these settings, reasonable standards include admission to a private room without connection to construction sites, and not allowing plants/cut flowers to be brought into the patient’s room. Patients at risk for mould infections are commonly managed as outpatients where engineering standards are not comparable to the “protected” environment of inpatients. We advise reasonable precautions to reduce mould exposure, including the avoidance of gardening, spreading mulch, or close exposure to construction or renovation. The effectiveness of masks (surgical or N95) to protect against mould infections associated with these exposures is unknown. The majority of cases of invasive mould infections are sporadic, although outbreaks are well-recognized PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UaGlvPC9BdXRob3I+PFllYXI+MjAwMDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [24]. In the absence of an outbreak with an identified environmental source (e.g. a contaminated air vent) or molecular analysis that demonstrates clustering of fungal isolates, it is not possible to reliably distinguish community-acquired from nosocomial aspergillosis. As a quality control measure, leukemia and transplant centers should perform regular surveillance (e.g. every 3 months) documenting the number of invasive mould infections within their institution. Due to the paucity of culture confirmed cases of IA and lack of autopsy data in most medical centers, surveillance using case definitions for moulds including GM and radiographic evidence of infection such as the revised European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) criteria is reasonable. An increase in incidence over baseline or the occurrence of invasive mould infections in patients who are not considered high-risk for such infections should prompt evaluation for a hospital source. Environmental sampling can provide important insight about sources of aspergillosis, including the spread of azole-resistant strains PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52YW4gZGVyIExpbmRlbjwvQXV0aG9yPjxZZWFyPjIwMTM8

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ADDIN EN.CITE.DATA [26, 27]. In the absence of an outbreak, there is insufficient evidence that environmental sampling of fungal spores is of value. In the setting of a documented or suspected nosocomial outbreak, a number of measures should be undertaken, including evaluation of the ventilation system to ensure adequate filtration, air flow, maintenance of positive pressure, and consideration of environmental sampling e.g., air vents and water system.What acquired or inherited defects in host immunity increase the risk of aspergillosis? Patients at risk for IA include those with prolonged neutropenia, allogeneic HSCT recipients, solid organ transplant recipients, patients receiving corticosteroids, advanced acquired immunodeficiency syndrome (AIDS), and CGD. In patients with hematologic malignancies, myelodysplastic syndrome, and other diseases associated with marrow failure (e.g., aplastic anemia), the intensity and duration of neutropenia predict the risk of IA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XZWluYmVyZ2VyPC9BdXRob3I+PFllYXI+MTk5MjwvWWVh

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ZE5vdGU+AG==

ADDIN EN.CITE.DATA [30]. In allogeneic HSCT recipients, three periods of risk for invasive mould disease occur: 1) neutropenia following the conditioning regimen; 2) exogenous immunosuppression for treatment of acute GVHD; and 3) exogenous immunosuppression for treatment of chronic GVHD (after day 100 of transplant). The level of allogeneic donor and recipient HLA disparity is the major determinant for GVHD severity and intensity of immunosuppression to control GVHD, which, in turn, is the major predisposing factor for opportunistic fungal infections PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb250b3lpYW5uaXM8L0F1dGhvcj48WWVhcj4yMDEwPC9Z

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Pn==

ADDIN EN.CITE.DATA [32, 33]. Among allogeneic HSCT recipients, polymorphisms in specific host defense genes of the donor or recipient can also influence the risk of aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb2NodWQ8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [34-37].In solid organ transplant recipients, the intensity of immunosuppression to prevent or treat allograft rejection, colonization, and coinfection with CMV drive the risk of invasive aspergillosis. As in allogeneic HSCT recipients, polymorphisms in specific host defense genes in solid organ transplant recipients can also influence the risk of aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Xb2p0b3dpY3o8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFy

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ADDIN EN.CITE.DATA [38, 39]. Lung transplant recipients have the highest risk of invasive aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXBwYXM8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [40-42]. In a multicenter surveillance study, approximately one-half of cases of invasive aspergillosis in lung transplant recipients were late-onset, occurring 1 year or more after transplantation ADDIN EN.CITE <EndNote><Cite><Author>Doligalski</Author><Year>2014</Year><RecNum>26021</RecNum><DisplayText>[41]</DisplayText><record><rec-number>26021</rec-number><foreign-keys><key app="EN" db-id="a9a0zdws9s90ave9xrmxtf9h90pw2dxzptep">26021</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Doligalski, C. T.</author><author>Benedict, K.</author><author>Cleveland, A. A.</author><author>Park, B.</author><author>Derado, G.</author><author>Pappas, P. G.</author><author>Baddley, J. W.</author><author>Zaas, D. W.</author><author>Harris, M. T.</author><author>Alexander, B. D.</author></authors></contributors><auth-address>Department of Pharmacy, Tampa General Hospital, Tampa, FL.</auth-address><titles><title>Epidemiology of invasive mold infections in lung transplant recipients</title><secondary-title>Am J Transplant</secondary-title><alt-title>American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons</alt-title></titles><periodical><full-title>Am J Transplant</full-title></periodical><pages>1328-33</pages><volume>14</volume><number>6</number><edition>2014/04/15</edition><dates><year>2014</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1600-6143 (Electronic)&#xD;1600-6135 (Linking)</isbn><accession-num>24726020</accession-num><work-type>Research Support, N.I.H., Extramural&#xD;Research Support, U.S. Gov&apos;t, P.H.S.</work-type><urls><related-urls><url>;[41]. CMV infection is a risk factor for aspergillosis, notably in heart and lung transplant recipients ADDIN EN.CITE <EndNote><Cite><Author>Singh</Author><Year>2013</Year><RecNum>515</RecNum><DisplayText>[43]</DisplayText><record><rec-number>515</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1432753735">515</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Singh, N.</author><author>Husain, S.</author><author>A. S. T. Infectious Diseases Community of Practice</author></authors></contributors><auth-address>VA Pittsburgh Healthcare System and University of Pittsburgh, Pittsburgh, PA, USA. nis5@pitt.edu</auth-address><titles><title>Aspergillosis in solid organ transplantation</title><secondary-title>Am J Transplant</secondary-title><alt-title>American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons</alt-title></titles><periodical><full-title>American Journal of Transplantation</full-title><abbr-1>Am. J. Transplant.</abbr-1><abbr-2>Am J Transplant</abbr-2></periodical><pages>228-41</pages><volume>13 Suppl 4</volume><keywords><keyword>Antifungal Agents/therapeutic use</keyword><keyword>*Aspergillosis/diagnosis/drug therapy/epidemiology/prevention &amp; control</keyword><keyword>Humans</keyword><keyword>*Organ Transplantation</keyword><keyword>Risk Factors</keyword></keywords><dates><year>2013</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1600-6143 (Electronic)&#xD;1600-6135 (Linking)</isbn><accession-num>23465016</accession-num><urls><related-urls><url>;[43]. Pre-transplant Aspergillus airway colonization is frequent among cystic fibrosis patients, and increases the risk of post-lung transplant invasive aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MdW9uZzwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [44]. Invasive aspergillosis in patients with autoimmune diseases is uncommon. Prolonged use of corticosteroids and other immunosuppressive agents and possibly pre-existing lung disease are risk factors ADDIN EN.CITE <EndNote><Cite><Author>Su</Author><Year>2009</Year><RecNum>797</RecNum><DisplayText>[45]</DisplayText><record><rec-number>797</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454362491">797</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Su, T.</author><author>Li, H. C.</author><author>Chen, M.</author><author>Gao, L.</author><author>Zhou, F. D.</author><author>Wang, R. G.</author><author>Zhang, H.</author><author>Li, X. M.</author><author>Zhao, M. H.</author></authors></contributors><auth-address>Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China.</auth-address><titles><title>Invasive pulmonary aspergillosis in patients with antineutrophil cytoplasmic antibody associated vasculitis</title><secondary-title>J Clin Rheumatol</secondary-title></titles><periodical><full-title>Journal of Clinical Rheumatology</full-title><abbr-1>J. Clin. Rheumatol.</abbr-1><abbr-2>J Clin Rheumatol</abbr-2></periodical><pages>380-2</pages><volume>15</volume><number>8</number><keywords><keyword>Aged</keyword><keyword>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/*drug</keyword><keyword>therapy/immunology</keyword><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>*Immunocompromised Host</keyword><keyword>Immunosuppressive Agents/*adverse effects</keyword><keyword>Invasive Pulmonary Aspergillosis/drug therapy/*immunology</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Retrospective Studies</keyword></keywords><dates><year>2009</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>1536-7355 (Electronic)&#xD;1076-1608 (Linking)</isbn><accession-num>19279506</accession-num><urls><related-urls><url>;[45]. In the era of highly active antiretroviral therapy, invasive aspergillosis is a rare complication of human immunodeficiency virus (HIV) infection. AIDS -associated aspergillosis is most frequently associated with advanced AIDS and additional risk factors, such as neutropenia, corticosteroid use, and concurrent opportunistic infections PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NeWxvbmFraXM8L0F1dGhvcj48WWVhcj4xOTk4PC9ZZWFy

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ADDIN EN.CITE.DATA [46, 47]. CGD, an inherited disorder of the phagocyte NADPH oxidase, is characterized by recurrent bacterial and fungal infections including IA, and other moulds, which can be life-threatening PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52YW4gZGVuIEJlcmc8L0F1dGhvcj48WWVhcj4yMDA5PC9Z

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ADDIN EN.CITE.DATA [48-51]. Several agents that target immune cell populations and signaling pathways, including malignancies and autoimmune disorders, have also been identified as risk factors for IA. For example, alemtuzumab (anti-CD52) can lead to neutropenia and prolonged suppression of cell-mediated immunity, potentially cytomegalovirus reactivation ADDIN EN.CITE <EndNote><Cite><Author>Skoetz</Author><Year>2012</Year><RecNum>26484</RecNum><DisplayText>[52]</DisplayText><record><rec-number>26484</rec-number><foreign-keys><key app="EN" db-id="a9a0zdws9s90ave9xrmxtf9h90pw2dxzptep">26484</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Skoetz, N.</author><author>Bauer, K.</author><author>Elter, T.</author><author>Monsef, I.</author><author>Roloff, V.</author><author>Hallek, M.</author><author>Engert, A.</author></authors></contributors><auth-address>Cochrane Haematological Malignancies Group, Department I of Internal Medicine, University Hospital of Cologne, Cologne,Germany. nicole.skoetz@uk-koeln.de.</auth-address><titles><title>Alemtuzumab for patients with chronic lymphocytic leukaemia</title><secondary-title>Cochrane Database Syst Rev</secondary-title><alt-title>The Cochrane database of systematic reviews</alt-title></titles><periodical><full-title>Cochrane Database Syst Rev</full-title></periodical><pages>CD008078</pages><volume>2</volume><edition>2012/02/18</edition><keywords><keyword>Antibodies, Monoclonal, Humanized/*therapeutic use</keyword><keyword>Antibodies, Monoclonal, Murine-Derived/therapeutic use</keyword><keyword>Antineoplastic Agents/*therapeutic use</keyword><keyword>Chlorambucil/therapeutic use</keyword><keyword>Humans</keyword><keyword>Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy/mortality</keyword><keyword>Randomized Controlled Trials as Topic</keyword><keyword>Vidarabine/analogs &amp; derivatives/therapeutic use</keyword></keywords><dates><year>2012</year></dates><isbn>1469-493X (Electronic)&#xD;1361-6137 (Linking)</isbn><accession-num>22336834</accession-num><work-type>Meta-Analysis&#xD;Research Support, Non-U.S. Gov&apos;t&#xD;Review</work-type><urls><related-urls><url>;[52], and subsequent IA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MdW5kaW48L0F1dGhvcj48WWVhcj4yMDAzPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [55]. An analysis of non-viral opportunistic infections in patients with autoimmune diseases documented the overall risk was greater in patients receiving TNF-α antagonists compared to non-biological disease-modifying antirheumatic drugs; however, IA was only observed in 1 of over 30,000 patients receiving a TNF-α antagonist PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYWRkbGV5PC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48

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ADDIN EN.CITE.DATA [56]. By contrast, the use of infliximab for severe GVHD is associated with high risk for the development of IA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJ0eTwvQXV0aG9yPjxZZWFyPjIwMDM8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [57]. Therefore, in assessing the risk for aspergillosis from a specific drug or antibody, one must consider all relevant factors, including the underlying disease being treated, comorbidities (e.g., pre-existing lung disease), neutropenia, and the use of concurrent immunosuppressive agents. IA has also been recognized in critically ill patients without traditional risk factors. The exact proportion of critically ill patients with IA in the absence of other risk factors is difficult to determine. In a retrospective analysis, Meersseman et al. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NZWVyc3NlbWFuPC9BdXRob3I+PFllYXI+MjAwNDwvWWVh

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ADDIN EN.CITE.DATA [58] identified 127 patients out of 1,850 intensive care unit (ICU) admissions (6.9%) with microbiological or histopathologic evidence of Aspergillus infection; however, only 5 of these patients had proven IA without predisposing host factors. Trials that evaluate clinical approaches to diagnose IA in critically ill patients include a substantial proportion with classic risk factors for IA and other risk factors including chronic obstructive pulmonary disease (COPD) and cirrhosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CbG90PC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [63], it is difficult to delineate the specific role of non-classic risk factors (e.g., multi-organ organ failure, prolonged mechanical ventilation, bacterial and viral infections including influenza) in driving the risk for IA.DIAGNOSIS OF ASPERGILLOSIS II. How can a diagnosis of IA be established?How should Aspergillus be identified and how does this influence management? Recommendation6.Until molecular tools are more widely used in clinical laboratories, we recommend that tissue and fluid specimens be submitted in adequate quantities for simultaneous histopathologic/cytologic and culture examination. In the case of isolates with atypical growth or concerns for resistance, species identification by molecular methods should be employed. (Strong Recommendation; High Quality Evidence).Evidence summaryThe EORTC/MSG revised criteria for defining invasive fungal infections, including IA, require a microbiologic and/or histopathologic diagnosis to define proven infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZSBQYXV3PC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48

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Tm90ZT4A

ADDIN EN.CITE.DATA [65-67]. Moreover, these methods are time consuming and insensitive. The most common specimens obtained are lung tissue by transthoracic percutaneous needle aspiration, or video assisted thoracoscopic biopsy, and bronchial lavage/wash specimens. These specimens should be submitted in adequate quantities for both histopathologic/cytologic testing and culture with a brief clinical history to aid the pathologist and microbiologist in interpretation of findings PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HdWFybmVyPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48

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ADDIN EN.CITE.DATA [68-72]. Methods to optimize yield should be employed including adequate quantity of specimens, timely delivery of fresh specimen to the laboratory, or refrigeration if delay is anticipated (although refrigeration may reduce the recovery of some organisms like the Mucorales), incubation of cultures for at least 5 days (and up to 3 weeks for other fungal pathogens) and communication of suspicion for fungal infection with pathology and microbiology laboratory personnel ADDIN EN.CITE <EndNote><Cite><Author>Labarca</Author><Year>1998</Year><RecNum>1111</RecNum><DisplayText>[73]</DisplayText><record><rec-number>1111</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1459876285">1111</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Labarca, J. A.</author><author>Wagar, E. A.</author><author>Grasmick, A. E.</author><author>Kokkinos, H. M.</author><author>Bruckner, D. A.</author></authors></contributors><auth-address>Department of Pathology and Laboratory Medicine, Clinical Microbiology Laboratory, UCLA Medical Center, University of California, Los Angeles, California, USA. jlabarca@ucla.edu</auth-address><titles><title>Critical evaluation of 4-week incubation for fungal cultures: is the fourth week useful?</title><secondary-title>J Clin Microbiol</secondary-title></titles><periodical><full-title>Journal of Clinical Microbiology</full-title><abbr-1>J. Clin. Microbiol.</abbr-1><abbr-2>J Clin Microbiol</abbr-2></periodical><pages>3683-5</pages><volume>36</volume><number>12</number><keywords><keyword>Fungi/*growth &amp; development/isolation &amp; purification</keyword><keyword>Humans</keyword><keyword>Retrospective Studies</keyword><keyword>Time Factors</keyword></keywords><dates><year>1998</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0095-1137 (Print)&#xD;0095-1137 (Linking)</isbn><accession-num>9817896</accession-num><urls><related-urls><url>;[73]. In the pathology laboratory, standard and special fungal stains on fluid or tissue should be performed simultaneously when a fungal infection is suspected and may reveal the characteristic acute angle branching septate hyphae of Aspergillus spp. Molecular assays targeting ribosomal DNA sequences can also be used for detection of Aspergillus in tissues, although these methods have not been standardized nor cleared by the FDA for clinical use. The optical brightener methods, Calcofluor or Blankophor, are rapid stains utilized for direct examination and have a high sensitivity and specificity for detecting Aspergillus-like features PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbmRyZWFzPC9BdXRob3I+PFllYXI+MjAwMDwvWWVhcj48

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ADDIN EN.CITE.DATA [76]. This low yield notwithstanding, culture is critical for species complex identification and susceptibility testing where feasible until molecular methods are more routinely performed in clinical laboratories.What is the diagnostic value of nucleic acid testing in clinical specimens?Recommendations7.There was debate among the committee members regarding the clinical utility of blood-based PCR in diagnosing IA and experts were not in agreement.? One group favored recommendations for PCR testing, based on publications validating its?role when used in conjunction with other tests such as antigen detection assays to diagnose IA and/or reduce pre-emptive antifungal usage.? The other group felt that PCR assays are promising, but could not be recommended for routine use in clinical practice at present due to the lack of conclusive validation for commercially available assays, the variety of?methodologies in the literature, and questions about the extent to which results assisted diagnosis.???8.As research in the area continues, we recommend that clinicians?choosing to?use PCR assays employ them carefully in the management of individual patients on a case-by-case basis.? Clinicians should be aware of the methodologies and performance?characteristics of the specific assay used, and interpret results accordingly.?When PCR assays are used, results should be considered in conjunction with other diagnostic tests and the clinical context (Strong Recommendation; Moderate Quality Evidence).?Evidence summarySince the last IDSA guidelines, there have been numerous publications assessing the performance of Aspergillus PCR in clinical samples. Overall, direct comparison studies have shown Aspergillus PCR to be substantially more sensitive than culture in blood and respiratory fluids. In a meta-analysis of clinical trials evaluating the accuracy of serum or whole-blood PCR assays for IA, sensitivity and specificity were 84% and 76%, respectively PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcnZhbml0aXM8L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFy

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ADDIN EN.CITE.DATA [77]. These values are promising, but PCR of blood or serum is unable on its own to confirm or exclude suspected IA in high-risk patients. The sensitivity of Aspergillus PCR on BAL fluid was higher than within blood, but in many instances its specificity was lower PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bdm5pPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [78, 79] . In a systematic review of nine studies using reference IA definitions strictly adherent to the EORTC/MSG criteria, the sensitivity and specificity of PCR of BAL were 77% and 94%, respectively ADDIN EN.CITE <EndNote><Cite><Author>Avni</Author><Year>2012</Year><RecNum>806</RecNum><DisplayText>[78]</DisplayText><record><rec-number>806</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454370457">806</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Avni, T.</author><author>Levy, I.</author><author>Sprecher, H.</author><author>Yahav, D.</author><author>Leibovici, L.</author><author>Paul, M.</author></authors></contributors><auth-address>Medicine E, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.</auth-address><titles><title>Diagnostic accuracy of PCR alone compared to galactomannan in bronchoalveolar lavage fluid for diagnosis of invasive pulmonary aspergillosis: a systematic review</title><secondary-title>J Clin Microbiol</secondary-title></titles><periodical><full-title>Journal of Clinical Microbiology</full-title><abbr-1>J. Clin. Microbiol.</abbr-1><abbr-2>J Clin Microbiol</abbr-2></periodical><pages>3652-8</pages><volume>50</volume><number>11</number><keywords><keyword>Bronchoalveolar Lavage Fluid/*microbiology</keyword><keyword>Case-Control Studies</keyword><keyword>Clinical Laboratory Techniques/*methods</keyword><keyword>Humans</keyword><keyword>Immunoassay/methods</keyword><keyword>Invasive Pulmonary Aspergillosis/*diagnosis</keyword><keyword>Mannans/*analysis</keyword><keyword>Mycology/*methods</keyword><keyword>Polymerase Chain Reaction/*methods</keyword><keyword>Prospective Studies</keyword><keyword>Retrospective Studies</keyword><keyword>Sensitivity and Specificity</keyword></keywords><dates><year>2012</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1098-660X (Electronic)&#xD;0095-1137 (Linking)</isbn><accession-num>22952268</accession-num><urls><related-urls><url>;[78] . Data included large 95% confidence intervals that were attributed to the use of different PCR assays and inclusion of heterogeneous patient populations PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Bdm5pPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [78, 79]. The lower specificity in BAL has been attributed to the fact that lungs are often colonized by Aspergillus (particularly in many high-risk populations, such as lung transplant recipients), and that PCR is not able to differentiate colonization from disease or to distinguish different Aspergillus spp. The high negative predictive value of BAL PCR (usually ≥95%) suggests a role in ruling out IPA. To date, data suggest that the diagnostic performance of blood or BAL PCR is comparable to that of serum and BAL GM index (GMI; ratio of the optical densities (OD) of the patient samples to the mean OD of control samples) of ≥0.5, respectively, and that sensitivity for both tests is affected by antifungal use. Using both PCR and GM in serum resulted in improved sensitivity with no sacrifice of specificity ADDIN EN.CITE <EndNote><Cite><Author>Avni</Author><Year>2012</Year><RecNum>806</RecNum><DisplayText>[78]</DisplayText><record><rec-number>806</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454370457">806</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Avni, T.</author><author>Levy, I.</author><author>Sprecher, H.</author><author>Yahav, D.</author><author>Leibovici, L.</author><author>Paul, M.</author></authors></contributors><auth-address>Medicine E, Rabin Medical Center, Beilinson Hospital, Petah-Tikva, Israel.</auth-address><titles><title>Diagnostic accuracy of PCR alone compared to galactomannan in bronchoalveolar lavage fluid for diagnosis of invasive pulmonary aspergillosis: a systematic review</title><secondary-title>J Clin Microbiol</secondary-title></titles><periodical><full-title>Journal of Clinical Microbiology</full-title><abbr-1>J. Clin. Microbiol.</abbr-1><abbr-2>J Clin Microbiol</abbr-2></periodical><pages>3652-8</pages><volume>50</volume><number>11</number><keywords><keyword>Bronchoalveolar Lavage Fluid/*microbiology</keyword><keyword>Case-Control Studies</keyword><keyword>Clinical Laboratory Techniques/*methods</keyword><keyword>Humans</keyword><keyword>Immunoassay/methods</keyword><keyword>Invasive Pulmonary Aspergillosis/*diagnosis</keyword><keyword>Mannans/*analysis</keyword><keyword>Mycology/*methods</keyword><keyword>Polymerase Chain Reaction/*methods</keyword><keyword>Prospective Studies</keyword><keyword>Retrospective Studies</keyword><keyword>Sensitivity and Specificity</keyword></keywords><dates><year>2012</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1098-660X (Electronic)&#xD;0095-1137 (Linking)</isbn><accession-num>22952268</accession-num><urls><related-urls><url>;[78]. Clinical trials incorporating biomarkers into the management of adults with hematologic malignancies or allogeneic HSCT have shown that the combined GM and PCR reduced use of antifungal treatment PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3JyaXNzZXk8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy

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ADDIN EN.CITE.DATA [81]. There have been fewer PCR studies using non-blood and non-BAL samples. In several studies, PCR is superior to culture in detecting Aspergillus spp. in sputum specimens from patients with CF and allergic or chronic pulmonary aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GcmFjemVrPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48

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ADDIN EN.CITE.DATA [82-86]. Small studies of Aspergillus PCR on non-blood and extra-pulmonary body fluids (pleural fluid, CSF, etc.) and paraffin-preserved and fresh tissues (lung, skin, sinus, lymph node) demonstrate sensitivity of 86% and specificity of 100% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWlud2FsZDwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+

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ADDIN EN.CITE.DATA [87-89]. Despite these promising results, Aspergillus PCR cannot yet be recommended for routine use in clinical practice because few assays have been standardized and validated, and the role of PCR testing in patient management is not established. Initiatives such as the European Aspergillus PCR Initiative (EAPCRI) have made significant progress in developing a consensus standard protocol for blood-based Aspergillus PCR. PCR assays are commercially available outside the US (MycAssay Aspergillus, Microgen Bioproducts Ltd, Camberley, UK); Septifast (Roche); MycoReal Aspergillus (Ingenetix GmbH); Affigene Aspergillus tracer (Cepheid); and Aspergillus spp. Q-PCR Alert (Nanogen); RenDx multiplex Aspergillus spp. & Candida spp. (whole blood, plasma & serum); AsperGenius (Pathonostics); Mycogenie (Ademtech) and others?) or centralization of PCR testing at a reference laboratory (ViraCor-IBT Laboratories (Lee’s Summit, MO)) and provide standardization but none have been cleared by the U.S. Food and Drug Administration (FDA) for clinical use in the U.S. These efforts now permit multi-center validation of assay performance and studies of clinical utility. Until such studies are completed, however, no specific recommendation about the role of Aspergillus PCR in clinical practice in the U.S. can be made.How should serum GM and (1→3)-β-D-glucan be used for the diagnosis of aspergillosis?Recommendations9.Serum and BAL GM is recommended as an accurate marker for the diagnosis of IA in adult and pediatric patients when used in certain patient subpopulations (hematologic malignancy, HSCT) (Strong Recommendation; High Quality Evidence). 10.GM is not recommended for routine blood screening in patients receiving mould-active antifungal therapy or prophylaxis, but can be applied to bronchoscopy specimens from those patients (Strong Recommendation; High Quality Evidence). 11.GM is not recommended for screening in solid organ transplant recipients or patients with CGD (Strong Recommendation; High Quality Evidence). 12.Serum assays for (1→3)-β-D-glucan are recommended for diagnosing IA in high risk patients (hematologic malignancy, allogeneic HSCT), but are not specific for Aspergillus (Strong Recommendation; Moderate Quality Evidence).Evidence summaryThe Platelia GM enzyme immunoassay (EIA) is a relatively Aspergillus-specific non-invasive diagnostic assay and several studies have demonstrated good sensitivity (~70%) in serum of patients with hematological malignancy or allogeneic HSCT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZXJicmVjaHQ8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFy

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ADDIN EN.CITE.DATA [90-95]. A GM-based diagnostic strategy can also result in less empiric antifungal therapy usage PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3JyaXNzZXk8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy

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ADDIN EN.CITE.DATA [103]. While earlier reports suggested that GM was not reliable in pediatric patients due to a high false-positive rate, several subsequent studies have shown its usefulness in children and similar operating characteristics to adult patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdGVpbmJhY2g8L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFy

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ADDIN EN.CITE.DATA [114]. GM in patients with CF colonized with Aspergillus species was consistently negative PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYXJyZW48L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [115]. Several variables, including concurrent mould-active antifungal therapy or prophylaxis, significantly reduce levels of circulating GM PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJyPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [91, 94]. The GMI may be increased in the setting of neutropenia and decreases in response to antifungal agents. In one study, the GMI in patients with absolute neutrophil count (ANC) <100/ ?l and not receiving antifungal therapy was statistically higher than those patients with an ANC >100/ ?l; however the GMI in patients with an ANC <100/?l and receiving antifungal therapy was not statistically different than those patients with an ANC >100 ?l. Laboratory data and clinical observations indicate that this effect may be due to a higher fungal burden in neutropenic patients, or a more robust inflammatory process in non-neutropenic patients with a corresponding decrease in the burden of disease, rate of dissemination, and GM release PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3Jkb25uaWVyPC9BdXRob3I+PFllYXI+MjAwOTwvWWVh

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ADDIN EN.CITE.DATA [116, 117].False-positive results have been reported in several contexts, including in patients who have received certain antibiotics (historically most notably piperacillin-tazobactam, which appears now to no longer be cross-reactive PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WZXJnaWRpczwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+

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ADDIN EN.CITE.DATA [119-122]. Despite these limitations, this assay is a useful adjunctive test to establish an early diagnosis, particularly when used in serial screening of patients at high risk of infection who are not receiving anti-mould prophylaxis. The optimal rationale for diagnosis in neutropenic patients may be a combined approach guided by clinical, radiographic, and bi-weekly screening of GM in serum PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2h3YXJ6aW5nZXI8L0F1dGhvcj48WWVhcj4yMDEzPC9Z

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ADDIN EN.CITE.DATA [123], possibly combined with other biomarkers. In patients receiving mould active antifungal prophylaxis, the use of serum GM as a screening tool results in a very poor predictive value with most positive tests being false positive in this setting ADDIN EN.CITE <EndNote><Cite><Author>Duarte</Author><Year>2014</Year><RecNum>173</RecNum><DisplayText>[124]</DisplayText><record><rec-number>173</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412206142">173</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Duarte, R. F.</author><author>Sanchez-Ortega, I.</author><author>Cuesta, I.</author><author>Arnan, M.</author><author>Patino, B.</author><author>Fernandez de Sevilla, A.</author><author>Gudiol, C.</author><author>Ayats, J.</author><author>Cuenca-Estrella, M.</author></authors></contributors><auth-address>Department of Hematology, Catalan Institute of Oncology - Hospital Duran i Reynals, Barcelona, Spain rduarte@.&#xD;Department of Hematology, Catalan Institute of Oncology - Hospital Duran i Reynals, Barcelona, Spain.&#xD;Centro Nacional de Microbiologia - Instituto de Salud Carlos III, Madrid, Spain.&#xD;Department of Microbiology, Hospital Universitario de Bellvitge, Barcelona, Spain.</auth-address><titles><title>Serum galactomannan-based early detection of invasive aspergillosis in hematology patients receiving effective anti-mold prophylaxis</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><dates><year>2014</year><pub-dates><date>Aug 27</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>25165088</accession-num><urls><related-urls><url>;[124]. The detection of GM in BAL fluid has been shown to have a sensitivity that exceeds 70% in most studies and provides additional sensitivity compared to cultures even in the setting of mould-active antifungal therapy as discussed below PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IdXNhaW48L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS

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Pn==

ADDIN EN.CITE.DATA [125-128]. Other potential circulating markers for detection of aspergillosis include (1→3)-β-D-glucan (BG) detected by the Tachypleus or Limulus assay PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Pc3Ryb3NreS1aZWljaG5lcjwvQXV0aG9yPjxZZWFyPjIw

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ADDIN EN.CITE.DATA [129, 130]. The Tachypleus or Limulus assay used to detect the presence of (1→3)-β-D-glucan is a variation of the limulus assay used to detect endotoxin. The presence of (1→3)-β-D-glucan in serum signifies the presence of fungal invasion but is not specific for Aspergillus species; other fungal diseases, including candidiasis, fusariosis, and Pneumocystis jirovecii pneumonia can result in a positive test. False-positive results can occur in a variety of contexts, such as through glucan contaminated blood collection tubes, gauze, depth-type membrane filters for blood processing, and various drugs (e.g., antibiotics including some cephalosporins, carbapenems, and ampicillin-sulbactam and possibly chemotherapeutics such as PEG asparaginase) ADDIN EN.CITE <EndNote><Cite><Author>Marty</Author><Year>2006</Year><RecNum>1260</RecNum><DisplayText>[131]</DisplayText><record><rec-number>1260</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1260</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Marty, F. M.</author><author>Lowry, C. M.</author><author>Lempitski, S. J.</author><author>Kubiak, D. W.</author><author>Finkelman, M. A.</author><author>Baden, L. R.</author></authors></contributors><auth-address>Division of Infectious Diseases, Brigham &amp; Women&apos;s Hospital, Boston, MA 02115, USA. fmarty@</auth-address><titles><title>Reactivity of (1--&gt;3)-beta-d-glucan assay with commonly used intravenous antimicrobials</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title><alt-title>Antimicrobial agents and chemotherapy</alt-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><alt-periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></alt-periodical><pages>3450-3</pages><volume>50</volume><number>10</number><edition>2006/09/29</edition><keywords><keyword>Anti-Bacterial Agents/administration &amp; dosage/ chemistry</keyword><keyword>False Positive Reactions</keyword><keyword>Humans</keyword><keyword>Injections, Intravenous</keyword><keyword>Mycoses/ diagnosis</keyword><keyword>Reagent Kits, Diagnostic</keyword><keyword>beta-Glucans/ analysis/ blood</keyword></keywords><dates><year>2006</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>0066-4804 (Print)&#xD;0066-4804 (Linking)</isbn><accession-num>17005829</accession-num><urls></urls><custom2>1610103</custom2><electronic-resource-num>10.1128/aac.00658-06</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[131]. The Fungitell assay (Associates of Cape Cod) for detection of (1→3)-β-D-glucan is cleared by the FDA for the diagnosis of invasive mycoses, including aspergillosis, and has been evaluated in high risk patients with hematological malignancy and allogeneic HSCT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PZGFiYXNpPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48

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ADDIN EN.CITE.DATA [137]. Other organizations have recommended the GM over Fungitell for specifically diagnosing IA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJjaGV0dGk8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFy

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ADDIN EN.CITE.DATA [138].What is the approach to the radiographic diagnosis of IPA?Recommendations13.We recommend performing a chest computed tomographic (CT) scan whenever there is a clinical suspicion for IPA regardless of chest radiograph results (Strong Recommendation; High Quality Evidence). 14.Routine use of contrast during a chest CT scan for a suspicion of IPA is not recommended (Strong Recommendation; Moderate Quality Evidence). Contrast is recommended when a nodule or a mass is close to a large vessel (Strong Recommendation; Moderate Quality Evidence). 15.We suggest a follow-up chest CT-scan to assess the response of IPA to treatment after a minimum of two weeks of treatment; earlier assessment is indicated if the patient clinically deteriorates (Weak Recommendation; Low Quality Evidence). When a nodule is close to a large vessel, more frequent monitoring may be required (Weak Recommendation; Low Quality Evidence).Evidence summaryAs clinical signs and symptoms are not specific for the diagnosis of IPA, radiographic imaging is critical. The role of imaging is to identify the site of infection, to assess the type, number and size of lesions, and local extension. Imaging also helps to direct diagnostic procedures (e.g. BAL or CT-guided biopsy) to the most appropriate area PEVuZE5vdGU+PENpdGUgRXhjbHVkZVllYXI9IjEiPjxBdXRob3I+QmVja2VyPC9BdXRob3I+PFll

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ADDIN EN.CITE.DATA [140], and high resolution computed tomography (HRCT, also called thin-section CT scanning with a thin collimation of 0.25 – 1 mm) is the preferred method. CT angiography may be a useful test pending further evaluation ADDIN EN.CITE <EndNote><Cite><Author>Stanzani</Author><Year>2015</Year><RecNum>507</RecNum><DisplayText>[141]</DisplayText><record><rec-number>507</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1432662686">507</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Stanzani, M.</author><author>Sassi, C.</author><author>Lewis, R. E.</author><author>Tolomelli, G.</author><author>Bazzocchi, A.</author><author>Cavo, M.</author><author>Vianelli, N.</author><author>Battista, G.</author></authors></contributors><auth-address>Institute of Hematology &quot;Lorenzo e Ariosto Seragnoli&quot;, Department of Hematology and Oncology.&#xD;Department of Experimental, Diagnostic and Specialty Medicine (DIMES), Division of Radiology.&#xD;Clinic of Infectious Diseases, Department of Internal Medicine Geriatrics and Nephrologic Diseases, S.Orsola-Malpighi Hospital, University of Bologna.&#xD;Diagnostic and Interventional Radiology, &quot;Rizzoli&quot; Institute, Bologna, Italy.</auth-address><titles><title>High resolution computed tomography angiography improves the radiographic diagnosis of invasive mold disease in patients with hematological malignancies</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>1603-10</pages><volume>60</volume><number>11</number><dates><year>2015</year><pub-dates><date>Jun 1</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>25722200</accession-num><urls><related-urls><url>;[141]. Chest CT-scan performed early after onset of fever helps to identify the cause of fever, may be informative before Aspergillus GM is positive and has been associated with an increased survival in febrile neutropenic patients who have received intensive chemotherapy for a hematologic malignancy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CdXNjYTwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [142-144]. Typical features of IPA on CT imaging include nodules, consolidative lesions, and wedge-shaped infarcts. Particularly in neutropenic patients, a halo sign, defined as a nodule (?1 cm in diameter) surrounded by a perimeter of ground-glass opacity reflecting hemorrhage, may be observed PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OdWNjaTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl

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PjwvRW5kTm90ZT4A

ADDIN EN.CITE.DATA [145-149]. Pleural effusions are occasionally observed. Appearance of an air crescent or a cavity in a mass, nodule or consolidation is also suggestive of invasive mould disease but is usually a later sign, often associated with recovery from neutropenia PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CcnVubzwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [147, 148]. The reverse halo sign is more frequently associated with pulmonary mucormycosis than with IPA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZWdvdWdlPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48

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ADDIN EN.CITE.DATA [152, 153]. The presence of nodules and a halo sign are characteristic of angioinvasion and this form of aspergillosis typically occurs in severely neutropenic patients. IPA can also affect the airways with bronchiolar wall destruction, presence of centrilobular micronodules and tree-in-bud opacities PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZXJnZXJvbjwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+

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Tm90ZT4A

ADDIN EN.CITE.DATA [155] but is the preferred imaging modality to identify and characterize osseous, paranasal sinus lesions, or central nervous system disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HYWJlbG1hbm48L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFy

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ADDIN EN.CITE.DATA [156-160].In neutropenic patients, pulmonary lesions usually increase in size during the first week following initiation of therapy and while the patient recovers from neutropenia PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYWlsbG90PC9BdXRob3I+PFllYXI+MjAwMTwvWWVhcj48

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ADDIN EN.CITE.DATA [161]. The size of lesions can increase up to 4-fold during the first week and then remain stable for another week. Repetition of a CT-scan before two weeks after the start of treatment is not usually recommended unless the patient experiences clinical deterioration. An exception is the presence of a nodule close to a large vessel because of the risk for massive hemoptysis if lesions continue to increase in size.What is the role of bronchoscopy in the diagnosis of IPA? Recommendations16.We recommend performing a bronchoscopy with bronchoalveolar lavage (BAL) in patients with a suspicion of IPA (Strong Recommendation; Moderate Quality Evidence) Significant comorbidities such as severe hypoxemia, bleeding, and platelet transfusion-refractory thrombocytopenia may preclude BAL. The yield of BAL is low for peripheral nodular lesions, so that percutaneous or endobronchial lung biopsy should be considered. We recommend the use of a standardized BAL procedure and sending the BAL sample for routine culture and cytology as well as non-culture-based methods (e.g. GM) (Strong Recommendation; Moderate Quality Evidence). Evidence summaryFlexible bronchoscopy with BAL remains the cornerstone for microbiological identification in diffuse interstitial or alveolar lung infiltrates, infiltrates in immunosuppressed patients, nosocomial pneumonia, or pneumonia with treatment failure PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYW1wc29uYXM8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFy

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ADDIN EN.CITE.DATA [162-165]. As radiographic signs and symptoms of IPA are nonspecific, BAL increases the likelihood of a diagnosis by direct or indirect identification of mould. BAL fluid analysis is based on gross observation (hemorrhage, alveolar proteinosis), cell count and differential count (macrophages, neutrophils, eosinophils, lymphocytes and subpopulation, erythrocytes, malignant cells), and on microbiologic tests (stains and immunohistochemistry, cultures, antigen or nucleic acid detection). Importantly, BAL allows in the same procedure, a search for bacterial, parasitic, viral, fungal pathogens as well as non-infectious causes of the pulmonary lesions.There is no uniform agreement on the best timing for bronchoscopy. In a survey of infectious diseases specialists, pulmonologists, and hematologists/oncologists, there was consensus that HSCT recipients who are non-neutropenic and do not have cavitary infiltrates on chest computed tomography scan should receive bronchoscopy only after a failure of empiric antimicrobial therapy. However, there was no agreement between the groups on when neutropenic patients or those with cavitary lesions should undergo bronchoscopy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWhsYTwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [166].BAL is an invasive procedure that requires instruction and consent from the patient, sufficient respiratory capacity of the patient, and no major bleeding diathesis. The British Thoracic Society has established guidelines on diagnostic flexible bronchoscopy ADDIN EN.CITE <EndNote><Cite><Author>Du Rand</Author><Year>2011</Year><RecNum>1021</RecNum><DisplayText>[167]</DisplayText><record><rec-number>1021</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454726034">1021</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Du Rand, I. A.</author><author>Barber, P. V.</author><author>Goldring, J.</author><author>Lewis, R. A.</author><author>Mandal, S.</author><author>Munavvar, M.</author><author>Rintoul, R. C.</author><author>Shah, P. L.</author><author>Singh, S.</author><author>Slade, M. G.</author><author>Woolley, A.</author><author>British Thoracic Society Interventional Bronchoscopy Guideline, Group</author></authors></contributors><auth-address>Queen Elizabeth Hospital, Birmingham, UK. ingrid.durand@</auth-address><titles><title>British Thoracic Society guideline for advanced diagnostic and therapeutic flexible bronchoscopy in adults</title><secondary-title>Thorax</secondary-title></titles><periodical><full-title>Thorax</full-title><abbr-1>Thorax</abbr-1><abbr-2>Thorax</abbr-2></periodical><pages>1-21</pages><volume>66 Suppl 3</volume><keywords><keyword>Adult</keyword><keyword>Brachytherapy</keyword><keyword>Bronchoscopy/*methods/standards</keyword><keyword>Cryotherapy</keyword><keyword>Electrocoagulation</keyword><keyword>Great Britain</keyword><keyword>Humans</keyword><keyword>Laser Therapy</keyword><keyword>Lung Diseases/*diagnosis/*therapy</keyword><keyword>Patient Selection</keyword><keyword>Photochemotherapy</keyword><keyword>Societies, Medical</keyword></keywords><dates><year>2011</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1468-3296 (Electronic)&#xD;0040-6376 (Linking)</isbn><accession-num>21987439</accession-num><urls><related-urls><url>;[167] and specific recommendations for the lavage procedure are also available PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXNsYW08L0F1dGhvcj48WWVhcj4xOTk5PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [168, 169].Sampsonas et al. evaluated a standardized procedure for BAL in 284 consecutive cancer patients with new pulmonary infiltrates ADDIN EN.CITE <EndNote><Cite><Author>Sampsonas</Author><Year>2011</Year><RecNum>306951</RecNum><DisplayText>[162]</DisplayText><record><rec-number>306951</rec-number><foreign-keys><key app="EN" db-id="f2pxvz2fxdwvr4e2pafppes1aewd9vdsefz5" timestamp="1412505870">306951</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sampsonas, F.</author><author>Kontoyiannis, D. P.</author><author>Dickey, B. F.</author><author>Evans, S. E.</author></authors></contributors><auth-address>Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, TX 77030-4009, USA.</auth-address><titles><title>Performance of a standardized bronchoalveolar lavage protocol in a comprehensive cancer center: a prospective 2-year study</title><secondary-title>Cancer</secondary-title><alt-title>Cancer</alt-title></titles><periodical><full-title>Cancer</full-title></periodical><alt-periodical><full-title>Cancer</full-title></alt-periodical><pages>3424-33</pages><volume>117</volume><number>15</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>*Bronchoalveolar Lavage Fluid</keyword><keyword>*Cancer Care Facilities</keyword><keyword>Female</keyword><keyword>Guideline Adherence</keyword><keyword>Humans</keyword><keyword>Lung Diseases/complications/*diagnosis</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Neoplasms/*complications</keyword><keyword>Prospective Studies</keyword></keywords><dates><year>2011</year><pub-dates><date>Aug 1</date></pub-dates></dates><isbn>1097-0142 (Electronic)&#xD;0008-543X (Linking)</isbn><accession-num>21246537</accession-num><urls><related-urls><url>;[162]. The majority of patients had a hematological malignancy. Thrombocytopenia was not considered a contraindication to bronchoscopy or BAL, but platelet transfusions were administered in patients who had platelet counts <20,000/?L. Only 10 BAL-related complications were observed and only one was serious but not fatal. In large series, major bronchoscopy-related complications rates range between 0.08 - and 0.5%, with mortality rates of 0 - 0.04%.Lavage is usually performed in the segmental or subsegmental bronchus of the most affected area of the lung based on a recent CT-scan ADDIN EN.CITE <EndNote><Cite><Author>Sampsonas</Author><Year>2011</Year><RecNum>306951</RecNum><DisplayText>[162]</DisplayText><record><rec-number>306951</rec-number><foreign-keys><key app="EN" db-id="f2pxvz2fxdwvr4e2pafppes1aewd9vdsefz5" timestamp="1412505870">306951</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sampsonas, F.</author><author>Kontoyiannis, D. P.</author><author>Dickey, B. F.</author><author>Evans, S. E.</author></authors></contributors><auth-address>Department of Pulmonary Medicine, The University of Texas MD Anderson Cancer Center, TX 77030-4009, USA.</auth-address><titles><title>Performance of a standardized bronchoalveolar lavage protocol in a comprehensive cancer center: a prospective 2-year study</title><secondary-title>Cancer</secondary-title><alt-title>Cancer</alt-title></titles><periodical><full-title>Cancer</full-title></periodical><alt-periodical><full-title>Cancer</full-title></alt-periodical><pages>3424-33</pages><volume>117</volume><number>15</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>*Bronchoalveolar Lavage Fluid</keyword><keyword>*Cancer Care Facilities</keyword><keyword>Female</keyword><keyword>Guideline Adherence</keyword><keyword>Humans</keyword><keyword>Lung Diseases/complications/*diagnosis</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Neoplasms/*complications</keyword><keyword>Prospective Studies</keyword></keywords><dates><year>2011</year><pub-dates><date>Aug 1</date></pub-dates></dates><isbn>1097-0142 (Electronic)&#xD;0008-543X (Linking)</isbn><accession-num>21246537</accession-num><urls><related-urls><url>;[162]. Saline is the most often used fluid. False positive Aspergillus GM detection tests were reported when Plasmalyte was used as fluid for BAL ADDIN EN.CITE <EndNote><Cite><Author>Hage</Author><Year>2007</Year><RecNum>36761</RecNum><DisplayText>[170]</DisplayText><record><rec-number>36761</rec-number><foreign-keys><key app="EN" db-id="f2pxvz2fxdwvr4e2pafppes1aewd9vdsefz5" timestamp="1399707209">36761</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hage, C. A.</author><author>Reynolds, J. M.</author><author>Durkin, M.</author><author>Wheat, L. J.</author><author>Knox, K. S.</author></authors></contributors><titles><title>Plasmalyte as a cause of false-positive results for Aspergillus galactomannan in bronchoalveolar lavage fluid</title><secondary-title>J Clin Microbiol</secondary-title><alt-title>Journal of clinical microbiology</alt-title></titles><periodical><full-title>Journal of Clinical Microbiology</full-title><abbr-1>J. Clin. Microbiol.</abbr-1><abbr-2>J Clin Microbiol</abbr-2></periodical><alt-periodical><full-title>Journal of Clinical Microbiology</full-title></alt-periodical><pages>676-7</pages><volume>45</volume><number>2</number><edition>2006/12/15</edition><keywords><keyword>Antigens, Fungal/analysis</keyword><keyword>Aspergillosis/*diagnosis</keyword><keyword>Aspergillus/immunology/*isolation &amp; purification</keyword><keyword>Bronchoalveolar Lavage Fluid/*microbiology</keyword><keyword>Electrolytes/*chemistry</keyword><keyword>*False Positive Reactions</keyword><keyword>Humans</keyword><keyword>Mannans/*analysis</keyword><keyword>Plasma Substitutes/*chemistry</keyword></keywords><dates><year>2007</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>0095-1137 (Print)&#xD;0095-1137 (Linking)</isbn><accession-num>17166959</accession-num><work-type>Letter</work-type><urls><related-urls><url>;[170]. There is considerable variation between practitioners in the volume instilled and the methods of lavage fluid collection and no consensus has been reached. The instilled volume in non-pediatric patients should be at least 100 mL (most commonly 100-150 mL in 20-50 mL aliquots, with the initial aliquot likely representing airway sampling) ADDIN EN.CITE <EndNote><Cite><Author>Baughman</Author><Year>2007</Year><RecNum>463</RecNum><DisplayText>[171]</DisplayText><record><rec-number>463</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1424892683">463</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Baughman, R. P.</author></authors></contributors><auth-address>Division of Pulmonary and Critical Care Medicine, University of Cincinnati Medical Center, Cincinnati, Ohio 45267-0565, USA. bob.baughman@uc.edu</auth-address><titles><title>Technical aspects of bronchoalveolar lavage: recommendations for a standard procedure</title><secondary-title>Semin Respir Crit Care Med</secondary-title><alt-title>Seminars in respiratory and critical care medicine</alt-title></titles><periodical><full-title>Seminars in Respiratory and Critical Care Medicine</full-title><abbr-1>Semin. Respir. Crit. Care Med.</abbr-1><abbr-2>Semin Respir Crit Care Med</abbr-2><abbr-3>Seminars in Respiratory &amp; Critical Care Medicine</abbr-3></periodical><alt-periodical><full-title>Seminars in Respiratory and Critical Care Medicine</full-title><abbr-1>Semin. Respir. Crit. Care Med.</abbr-1><abbr-2>Semin Respir Crit Care Med</abbr-2><abbr-3>Seminars in Respiratory &amp; Critical Care Medicine</abbr-3></alt-periodical><pages>475-85</pages><volume>28</volume><number>5</number><keywords><keyword>Bronchoalveolar Lavage/methods/*standards</keyword><keyword>Bronchoalveolar Lavage Fluid/chemistry/cytology</keyword><keyword>Humans</keyword><keyword>Lung Diseases, Interstitial/diagnosis</keyword><keyword>Specimen Handling/methods</keyword></keywords><dates><year>2007</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1069-3424 (Print)&#xD;1069-3424 (Linking)</isbn><accession-num>17975775</accession-num><urls><related-urls><url>;[171]. BAL samples should be sent for cytologic assessment, Gram staining, fungal staining (e.g., Calcofluor white or GMS stain), culture and GM. 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Pn==

ADDIN EN.CITE.DATA [125-128]. The optimal threshold for GM positivity has not been determined; an OD of 1.0 has been cleared by the FDA for clinical testing although some experts consider positivity at an OD > 0.5. A higher threshold OD index results in a lower sensitivity, but a higher specificity PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EJmFwb3M7SGFlc2U8L0F1dGhvcj48WWVhcj4yMDEyPC9Z

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ADDIN EN.CITE.DATA [128]. The diagnostic yield of BAL also varies by the type of radiographic lesion ADDIN EN.CITE <EndNote><Cite><Author>Brownback</Author><Year>2013</Year><RecNum>306985</RecNum><DisplayText>[172]</DisplayText><record><rec-number>306985</rec-number><foreign-keys><key app="EN" db-id="f2pxvz2fxdwvr4e2pafppes1aewd9vdsefz5" timestamp="1412920287">306985</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Brownback, K. R.</author><author>Simpson, S. Q.</author></authors></contributors><auth-address>Division of Pulmonary and Critical Care Medicine, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, USA.</auth-address><titles><title>Association of bronchoalveolar lavage yield with chest computed tomography findings and symptoms in immunocompromised patients</title><secondary-title>Ann Thorac Med</secondary-title><alt-title>Annals of thoracic medicine</alt-title></titles><periodical><full-title>Annals of Thoracic Medicine</full-title><abbr-1>Ann. Thorac. Med.</abbr-1><abbr-2>Ann Thorac Med</abbr-2></periodical><alt-periodical><full-title>Annals of Thoracic Medicine</full-title><abbr-1>Ann. Thorac. Med.</abbr-1><abbr-2>Ann Thorac Med</abbr-2></alt-periodical><pages>153-9</pages><volume>8</volume><number>3</number><dates><year>2013</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1817-1737 (Print)&#xD;1998-3557 (Linking)</isbn><accession-num>23922610</accession-num><urls><related-urls><url>;[172]. In this study there was no difference in the diagnostic yield between focal and diffuse infiltrates (54% vs. 52%). In consolidations and “tree-in-bud” type abnormalities the yield is close to 70%, while in ground-glass, reticular, or nodular lesions the diagnostic yield falls to ~50%. Transbronchial biopsies are not generally recommended due to their low yield and frequent patient comorbidities such as thrombocytopenia that preclude this diagnostic approach. A percutaneous needle biopsy may be more sensitive than BAL for small peripheral pulmonary lesions.III. What antifungal agents are available for the treatment and prophylaxis of IA including pharmacologic considerations and what is the role for susceptibility testing? Amphotericin BRecommendations17.AmB deoxycholate and its lipid derivatives are appropriate options for initial and salvage therapy of Aspergillus infections when voriconazole cannot be administered. However, AmB deoxycholate should be reserved for use in resource-limited settings in which no alternative agents are available. Lipid formulations of AmB should be considered in settings in which azoles are contraindicated or not tolerated (Strong Recommendation; Moderate Quality Evidence).18.Aerosolized formulations of AmB may be considered as prophylaxis in patients with prolonged neutropenia (patients receiving induction/re-induction therapy for acute leukemia and allogeneic HSCT recipients following conditioning or during treatment of GVHD) and in lung transplant recipients (Weak Recommendation; Low Quality Evidence).Evidence summaryAmB is a polyene with poor oral absorption and is thus solubilized with deoxycholate for intravenous administration. Alternative routes of administration are intraperitoneal, intravitreal, intrathecal, bladder irrigation, and aerosolization. The primary mechanism of action of AmB has historically been considered due to the formation of ion channels in the fungal cell membrane but recent evidence suggests that amphotericin forms large extramembranous aggregates that extract ergosterol from lipid bilayers resulting in cell death PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbmRlcnNvbjwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+

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ADDIN EN.CITE.DATA [173]. Binding to cholesterol in mammalian cell membranes results in end organ dysfunction. A second mechanism of action involves oxidative cell membrane damage. AMB is highly protein bound (95%) before distribution predominantly into reticuloendothelial tissues and kidney. Peak serum concentrations of 1-2 mcg/ml are achieved following infusion of 30-50 mg. Penetration into intact and inflamed meninges is poor. No metabolites have been identified. Drug elimination is biphasic with a terminal half-life for AmB deoxycholate of up to 15 days and the primary route of elimination is not known. Serum levels are not influenced by hepatic or renal dysfunction and it is poorly dialyzed. Doses of deoxycholate AmB range from 0.1-1.5 mg/kg daily. With drug-related renal dysfunction, 50% dose reduction or alternate day dosing may be considered. Adverse events include acute infusion reactions (nausea, chills, and rigors), administration site phlebitis, and nephrotoxicity (azotemia, urinary potassium/magnesium wasting, renal tubular acidosis). Azotemia is exacerbated by concomitant administration of nephrotoxic agents, underlying renal impairment, and diabetes. Volume expansion with a salt load immediately prior to AmB dosing, and monitoring of potassium and magnesium, with repletion as needed, are warranted to prevent renal toxicity. Utility of 24-hour infusions is limited. AmB is active against most, but not all, Aspergillus species.Lipid-based formulations of AmB were developed to reduce AmB-related nephrotoxicity. Available formulations are AmB lipid complex (ABLC, AbelcetTM), AmB colloidal dispersion, (ABCD, AmphocilTM, AmphotecTM), and liposomal AmB (AmBisomeTM). Their pharmacokinetic profiles differ from AmB deoxycholate, as well as between each formulation. All preferentially distribute to reticuloendothelial tissue. Infusion reactions of fever and chills occur commonly with ABLC. A characteristic infusion-related reaction syndrome of dyspnea, chest pain, back pain, and hypoxia also may occur particularly with liposomal AmB PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb2RlbjwvQXV0aG9yPjxZZWFyPjIwMDM8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [174]. In addition to hypokalemia and hypomagnesemia, mild bilirubin and alkaline phosphatase elevations may occur. Idiosyncratic reactions to one preparation do not preclude use of other formulations ADDIN EN.CITE <EndNote><Cite><Author>Farmakiotis</Author><Year>2013</Year><RecNum>643</RecNum><DisplayText>[175]</DisplayText><record><rec-number>643</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1439315568">643</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Farmakiotis, D.</author><author>Tverdek, F. P.</author><author>Kontoyiannis, D. P.</author></authors></contributors><auth-address>Department of Infectious Diseases, Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.</auth-address><titles><title>The safety of amphotericin B lipid complex in patients with prior severe intolerance to liposomal amphotericin B</title><secondary-title>Clin Infect Dis</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>701-3</pages><volume>56</volume><number>5</number><keywords><keyword>Adult</keyword><keyword>Amphotericin B/*adverse effects</keyword><keyword>Antifungal Agents/*adverse effects</keyword><keyword>Drug-Related Side Effects and Adverse Reactions</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infusion Pumps/adverse effects</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Neoplasms/*drug therapy</keyword><keyword>Retrospective Studies</keyword><keyword>Tertiary Care Centers</keyword></keywords><dates><year>2013</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>23166189</accession-num><urls><related-urls><url>;[175]. Approved dosages for aspergillosis therapy are: 5, 3-6, and 3-5 mg/kg/day for ABLC, ABCD, and liposomal AmB, respectively PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3dkZW48L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [177]. Aerosolized formulations of AmB have been used as prophylaxis. Lipid formulations of AmB are generally better tolerated than those involving AmB deoxycholate. Serum drug levels are negligible. These formulations have been utilized as prophylaxis in patients with prolonged neutropenia (patients receiving induction/re-induction therapy for acute leukemia and allogeneic HSCT recipients following conditioning) and in lung (with or without heart) transplant recipients, and therapeutically in recalcitrant fungal lung infections PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3JybzwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [178-186].EchinocandinsRecommendations19.Echinocandins are effective in salvage therapy (either alone or in combination) against IA, but we do not recommend their routine use as monotherapy for the primary treatment of IA (Strong Recommendation: Moderate Quality Evidence). Evidence summaryEchinocandins are semisynthetic amphiphilic lipopeptide antifungal agents. Each of these large molecules is composed of a cyclic hexapeptide core linked to a variably configured N-linked fatty acyl side chain ADDIN EN.CITE <EndNote><Cite><Author>Denning</Author><Year>2003</Year><RecNum>7</RecNum><DisplayText>[187]</DisplayText><record><rec-number>7</rec-number><foreign-keys><key app="EN" db-id="ew5evr9aorzss7epavcvz99kv5we95dwfrsw">7</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Denning, D. W.</author></authors></contributors><auth-address>Education and Research Centre, Wythenshawe Hospital, Southmoor Road, M23 9LT, Manchester, UK. ddenning@man.ac.uk</auth-address><titles><title>Echinocandin antifungal drugs</title><secondary-title>Lancet</secondary-title><alt-title>Lancet</alt-title></titles><periodical><full-title>Lancet</full-title><abbr-1>Lancet</abbr-1></periodical><alt-periodical><full-title>Lancet</full-title><abbr-1>Lancet</abbr-1></alt-periodical><pages>1142-51</pages><volume>362</volume><number>9390</number><edition>2003/10/11</edition><keywords><keyword>Amphotericin B/therapeutic use</keyword><keyword>Antifungal Agents/adverse effects/*therapeutic use</keyword><keyword>Aspergillosis/*drug therapy</keyword><keyword>Candidiasis/*drug therapy</keyword><keyword>Clinical Trials as Topic</keyword><keyword>Echinocandins</keyword><keyword>*Fungal Proteins</keyword><keyword>Humans</keyword><keyword>Lipopeptides</keyword><keyword>Lipoproteins/therapeutic use</keyword><keyword>Peptides/therapeutic use</keyword><keyword>Peptides, Cyclic/therapeutic use</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2003</year><pub-dates><date>Oct 4</date></pub-dates></dates><isbn>1474-547X (Electronic)&#xD;0140-6736 (Linking)</isbn><accession-num>14550704</accession-num><work-type>Clinical Trial&#xD;Comparative Study&#xD;Review</work-type><urls><related-urls><url>(03)14472-8</electronic-resource-num><language>eng</language></record></Cite></EndNote>[187]. The echinocandins act by noncompetitive inhibition of the synthesis of (1→3)-β-D-glucan, a polysaccharide in the cell wall of many pathogenic fungi. Together with chitin, these rope-like glucan fibrils are responsible for the cell wall's strength and shape. They are important in maintaining the osmotic integrity of the fungal cell and play a key role in cell division and cell growth. Each echinocandin has a half-life of greater than 10 hours, which allows for once-daily dosing. They exhibit dose-proportional plasma pharmacokinetics. Echinocandins are highly (>95%) protein bound and distribute well into all major organ sites except for the eye, uninfected spinal fluid where concentrations are lower than other body tissues, and in urine where concentrations are also low. They are available for parenteral administration only. Anidulafungin undergoes spontaneous chemical degradation, with fragment elimination in bile. Caspofungin is metabolized by the liver with some additional spontaneous chemical degradation, with a recommendation for a dose reduction in cases of markedly reduced hepatic function. Micafungin is metabolized by the catechol-O-methyltransferase pathway.Echinocandins are generally well tolerated, with few side effects and few drug interactions. Caspofungin administration in children and adolescents provides exposure that is comparable to that obtained in adults PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWxzaDwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [189], as well as between clearance and weight ADDIN EN.CITE <EndNote><Cite><Author>Hall</Author><Year>2011</Year><RecNum>828</RecNum><DisplayText>[190]</DisplayText><record><rec-number>828</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454438385">828</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hall, R. G.</author><author>Swancutt, M. A.</author><author>Gumbo, T.</author></authors></contributors><auth-address>Texas Tech University Health Sciences Center and UT Southwestern Medical Center,2 Dallas, Texas 75390-9113, USA.</auth-address><titles><title>Fractal geometry and the pharmacometrics of micafungin in overweight, obese, and extremely obese people</title><secondary-title>Antimicrob Agents Chemother</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob. Agents Chemother.</abbr-1><abbr-2>Antimicrob Agents Chemother</abbr-2><abbr-3>Antimicrobial Agents &amp; Chemotherapy</abbr-3></periodical><pages>5107-12</pages><volume>55</volume><number>11</number><keywords><keyword>Adult</keyword><keyword>Antifungal Agents/*pharmacokinetics</keyword><keyword>Body Mass Index</keyword><keyword>Body Weight/physiology</keyword><keyword>Echinocandins/*pharmacokinetics</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Lipopeptides/*pharmacokinetics</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Obesity/*metabolism</keyword><keyword>Overweight/*metabolism</keyword><keyword>Young Adult</keyword></keywords><dates><year>2011</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1098-6596 (Electronic)&#xD;0066-4804 (Linking)</isbn><accession-num>21876061</accession-num><urls><related-urls><url>;[190], so micafungin dosing is individualized in patients aged eight years and younger, and in extremely obese patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZWliZWw8L0F1dGhvcj48WWVhcj4yMDA1PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [189, 190]. Both caspofungin and micafungin maintain linear pharmacokinetics when dose escalated in adult patients with IA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XdXJ0aHdlaW48L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy

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ADDIN EN.CITE.DATA [191, 192]. Among the three compounds, caspofungin has more extensive hepatic metabolism, leading to some interactions with other medications. For example, caspofungin can reduce the area under the curve of tacrolimus by ～20%, but has no effect on cyclosporine levels. In contrast, cyclosporine increases the area under the curve of caspofungin by ～35%. Inducers of drug clearance and/or mixed inducer/inhibitors, namely efavirenz, nelfinavir, nevirapine, phenytoin, rifampin, dexamethasone, and carbamazepine, may reduce caspofungin concentrations. All three agents have activity against Aspergillus species. Data are limited regarding their use for primary treatment of invasive infections, due to low accrual in clinical trials. Use of caspofungin to treat 24 allogeneic HSCT recipients with 12 weeks of therapy led to a 42% complete or partial infection response, with a 12-week survival of 50% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZXJicmVjaHQ8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFy

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ADDIN EN.CITE.DATA [193]. However, in a second stratum of that study, primary therapy with caspofungin was successful in only 20/61 (33%) patients. with hematological malignancy. Based on this limited database, echinocandin monotherapy is not routinely recommended as primary treatment for IA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WaXNjb2xpPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48

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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WaXNjb2xpPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48

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ADDIN EN.CITE.DATA [194]. Use of micafungin to treat 50 patients with chronic pulmonary aspergillosis led to a 60% treatment response PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2hubzwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl

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AG==

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AG==

ADDIN EN.CITE.DATA [195]. As a result of the difficulty in enrolling patients at the point of needing primary treatment for aspergillosis, patients with Aspergillus infections were more frequently studied once their infections became refractory to or intolerant of other approved therapies, i.e., salvage therapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZW5uaW5nPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [196-198]. In a study where 326 patients were treated with micafungin as salvage therapy, there was a 44% survival rate by the end of six weeks of follow-up, with 59% of deaths attributable to the Aspergillus infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZW5uaW5nPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [197]. Although anidulafungin has been studied in combination therapy, it has not been evaluated in monotherapy as primary or salvage therapy for IA. Because of their distinct mechanism of action, the echinocandins have the potential for use in combination regimens with antifungal agents of differing mechanisms of action PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZW5uaW5nPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [196, 198-200]. When patients are treated with combination therapy, the impact of the echinocandin agent is difficult to specifically define. TriazolesRecommendations20.Triazoles are preferred agents for treatment and prevention of IA in most patients (Strong Recommendation; High Quality Evidence). Evidence SummaryTRIAZOLE PHARMACOLOGY ItraconazoleItraconazole is formulated as capsules and an oral solution in hydroxypropyl-β-cyclodextrin (HPCD), and a parenteral solution, which is no longer sold in the U.S., that also uses HPCD as solubilizing agent. Accumulation of the cyclodextrin molecule in the intravenous preparation occurs with renal impairment although the toxicity of accumulated cyclodextrin in humans is uncertain. Systemic absorption of oral cyclodextrin is minimal thus the use of the oral solution is not impacted by renal insufficiency. Itraconazole is highly protein bound (>99%) and is extensively metabolized by the liver (CYP3A4) and undergoes enterohepatic circulation. The hydroxyitraconazole metabolite has approximately equivalent antifungal activity but with variable plasma concentration as native drug. Both must be measured to assess drug bioavailability. Itraconazole is an inhibitor and substrate for CYP3A4 and inhibitor of the permeability glycoprotein (p-gp) membrane transporter. The metabolites are excreted in the urine (40%) and bile (55%) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TbGFpbjwvQXV0aG9yPjxZZWFyPjIwMDE8L1llYXI+PFJl

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RW5kTm90ZT5=

ADDIN EN.CITE.DATA [201, 202]. Significant pharmacokinetic variation exists between patients in absorption and distribution PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MYXpvIGRlIGxhIFZlZ2E8L0F1dGhvcj48WWVhcj4xOTk0

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ADDIN EN.CITE.DATA [206]. Negative inotropic effects have been observed uncommonly but may be important in patients with ventricular dysfunction. Itraconazole is a substrate of CYP3A4 but also interacts with the heme moiety of CYP3A4, resulting in noncompetitive inhibition of oxidative metabolism of many CYP3A4 substrates. Serious interactions with some chemotherapeutic agents (e.g., cyclophosphamide and vincristine) may require additional monitoring to avoid toxicity ADDIN EN.CITE <EndNote><Cite><Author>Marr</Author><Year>2004</Year><RecNum>1685</RecNum><DisplayText>[207]</DisplayText><record><rec-number>1685</rec-number><foreign-keys><key app="EN" db-id="pfsvzxeth5zrr8epf5yxdef25xrpedt2tpfp">1685</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Marr, K. A.</author><author>Leisenring, W.</author><author>Crippa, F.</author><author>Slattery, J. T.</author><author>Corey, L.</author><author>Boeckh, M.</author><author>McDonald, G. B.</author></authors></contributors><auth-address>Program in Infectious Diseases, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, D3-100, Seattle, WA 98109, USA. kmarr@</auth-address><titles><title>Cyclophosphamide metabolism is affected by azole antifungals</title><secondary-title>Blood</secondary-title><alt-title>Blood</alt-title></titles><periodical><full-title>Blood</full-title><abbr-1>Blood</abbr-1></periodical><alt-periodical><full-title>Blood</full-title><abbr-1>Blood</abbr-1></alt-periodical><pages>1557-9</pages><volume>103</volume><number>4</number><edition>2003/09/25</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Antifungal Agents/ administration &amp; dosage</keyword><keyword>Antineoplastic Agents, Alkylating/ pharmacokinetics</keyword><keyword>Bone Marrow Transplantation</keyword><keyword>Candidiasis/ prevention &amp; control</keyword><keyword>Cyclophosphamide/ pharmacokinetics</keyword><keyword>Drug Interactions</keyword><keyword>Fluconazole/ administration &amp; dosage</keyword><keyword>Humans</keyword><keyword>Itraconazole/ administration &amp; dosage</keyword></keywords><dates><year>2004</year><pub-dates><date>Feb 15</date></pub-dates></dates><isbn>0006-4971 (Print)&#xD;0006-4971 (Linking)</isbn><accession-num>14504090</accession-num><urls></urls><electronic-resource-num>10.1182/blood-2003-07-2512</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[207] as well as other agents that prolong the QTc. Because of these limitations itraconazole is rarely recommended in patients with acute IPA with its use reserved for patients with less severe or less invasive disease presentations.Voriconazole Voriconazole is formulated as tablets, an oral suspension, and as a sulfobutyl-ether cyclodextrin solution for IV administration. Sulfobutyl-ether cyclodextrin and voriconazole dissociate in plasma and the cyclodextrin molecule is renally cleared. Accumulation of the vehicle occurs with renal insufficiency. Renal toxicity of hydroxypropyl β-cyclodextrin after parenteral administration has been demonstrated in animal models, although no deleterious effects on renal function have been observed in humans PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GcmFuazwvQXV0aG9yPjxZZWFyPjE5NzY8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [208, 209]; for this reason, the consequences of cyclodextrin plasma accumulation are unclear. The relative benefits and uncertain risks of intravenous administration of voriconazole in the context of IA and renal failure should be determined on an individual patient basis. This concern does not apply to orally administered voriconazole. The oral formulation has good bioavailability in the fed or fasted state. Voriconazole is hepatically metabolized, with only 5% of the drug appearing unchanged in the urine. This agent exhibits nonlinear pharmacokinetics in adults, with the maximum concentration in plasma and area under the curve increasing disproportionally with increasing dose. Voriconazole is both a substrate and an inhibitor of CYP2C19 primarily, as well as of CYP3A4 PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IeWxhbmQ8L0F1dGhvcj48WWVhcj4yMDAzPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [213]. Single-nucleotide polymorphisms contributing to slow metabolism are represented in higher frequencies among non-Indian Asian populations than among other populations.Factors affecting voriconazole pharmacokinetics include patient age, liver function, CYP2C19- and CYP3A-interacting medications, diet and antacids, proton pump inhibitors, patient weight, as well as the drug dose and formulation ADDIN EN.CITE <EndNote><Cite><Author>Mikus</Author><Year>2011</Year><RecNum>503</RecNum><DisplayText>[214]</DisplayText><record><rec-number>503</rec-number><foreign-keys><key app="EN" db-id="pfsvzxeth5zrr8epf5yxdef25xrpedt2tpfp">503</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mikus, G.</author><author>Scholz, I. M.</author><author>Weiss, J.</author></authors></contributors><auth-address>Department of Clinical Pharmacology &amp; Pharmacoepidemiology, University Hospital of Heidelberg, Im Neuenheimer Feld 410, 69120 Heidelberg, Germany. gerd.mikus@med.uni-heidelberg.de</auth-address><titles><title>Pharmacogenomics of the triazole antifungal agent voriconazole</title><secondary-title>Pharmacogenomics</secondary-title><alt-title>Pharmacogenomics</alt-title></titles><periodical><full-title>Pharmacogenomics</full-title><abbr-1>Pharmacogenomics</abbr-1></periodical><alt-periodical><full-title>Pharmacogenomics</full-title><abbr-1>Pharmacogenomics</abbr-1></alt-periodical><pages>861-72</pages><volume>12</volume><number>6</number><edition>2011/06/23</edition><keywords><keyword>Antifungal Agents/adverse effects/ pharmacokinetics</keyword><keyword>Aryl Hydrocarbon Hydroxylases/ genetics/metabolism</keyword><keyword>Drug Interactions</keyword><keyword>Humans</keyword><keyword>Pharmacogenetics</keyword><keyword>Pyrimidines/adverse effects/ pharmacokinetics</keyword><keyword>Triazoles/adverse effects/ pharmacokinetics</keyword></keywords><dates><year>2011</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1744-8042 (Electronic)&#xD;1462-2416 (Linking)</isbn><accession-num>21692616</accession-num><urls></urls><electronic-resource-num>10.2217/pgs.11.18</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[214]. Reduced voriconazole levels may be observed with oral administration of the drug (vs. intravenous), and coadministration with rifampin or phenytoin PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2x0b248L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS

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dGU+

ADDIN EN.CITE.DATA [215, 216]. Measurement of serum levels is useful in the majority of patients, both to evaluate for potential toxicity or to document adequate drug exposure, especially in progressive infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2x0b248L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [218, 222, 229]. The profile of adverse reactions to voriconazole includes transient visual disturbances (characterized principally by photopsia); hepatotoxicity, which may be dose limiting (manifested by elevated serum bilirubin, alkaline phosphatase, and hepatic aminotransferase enzyme levels); skin rash, erythroderma, photosensitivity, and perioral excoriations; nausea, vomiting, and diarrhea; visual or auditory hallucinations; and cardiovascular events including tachyarrhythmias and QT interval prolongations on the electrocardiogram PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3VjaGVyPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48

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ADDIN EN.CITE.DATA [229, 231]. Mild hepatotoxicity is common as for all azoles and related to drug concentration PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3lkPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [229, 232, 233]. Severe hepatotoxicity is uncommon. Reversible central and peripheral neurologic symptoms and hallucinations may be observed in association with higher drug concentrations but with significant variability; these may be confused with other etiologies of CNS dysfunction including posterior reversible leukoencephalopathy syndrome (PRES) or calcineurin inhibitor toxicity PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XdTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJlY051

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ADDIN EN.CITE.DATA [219, 226, 229, 234, 235]. Voriconazole concentrations may be a predictor of CNS neurotoxicity which is reversible PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2x0b248L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [216]. The use of prolonged voriconazole therapy (as for osteomyelitis or meningitis) or prophylaxis has revealed newer toxicities including periostitis with severe pain in bones or joints in association with elevated serum fluoride levels PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CdWNrbm9yPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48

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ADDIN EN.CITE.DATA [236-242]. The risk for squamous cell skin cancer or melanoma in sun-exposed areas is enhanced by concomitant immunosuppression and chronic voriconazole use, especially in fair skinned persons PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NY0xhdWdobGluPC9BdXRob3I+PFllYXI+MjAxMzwvWWVh

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ADDIN EN.CITE.DATA [243-245].PosaconazolePosaconazole, which is structurally similar to itraconazole, is available as an oral suspension, delayed release tablet and intravenous formulation but has been studied for the treatment and prophylaxis of IA only in the oral suspension in efficacy studies. Posaconazole exhibits not only linear kinetics but also saturable absorption of the suspension; thus, oral loading doses are not possible. Steady-state levels may not be achieved for up to a week with posaconazole therapy, which impacts use in primary therapy. The newer delayed release tablet formulation has improved bioavailability and is given once daily PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5KdW5nPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [246-248] as is the intravenous formulation in β-cyclodextrin. Bioavailability of the new tablet is not affected by food or gastric acid, but the oral suspension requires a fed state to maximize bioavailability. Posaconazole undergoes hepatic metabolism via glucuronidation and also has the capacity for drug-drug interactions through inhibition of cytochrome P450 (CYP450) 3A4 isoenzymes PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYW5jaGV6LU9ydGVnYTwvQXV0aG9yPjxZZWFyPjIwMTI8

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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TYW5jaGV6LU9ydGVnYTwvQXV0aG9yPjxZZWFyPjIwMTI8

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ADDIN EN.CITE.DATA [249]. Posaconazole pharmacokinetics are variable between patients and therapeutic drug monitoring seems useful, although the posaconazole exposure in plasma from the oral solution appears to underestimate the clinical response to therapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HdWJiaW5zPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [255] but may be increased with the higher serum levels attained with the delayed release tablets. Other toxicities including prolonged QTc have been reported with the increased drug levels associated with the extended release tablets. Therapeutic drug monitoring is recommended based on both preclinical and clinical trials with the oral solution which documented variable absorption and the relationship of levels to efficacy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5VbGxtYW5uPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48

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ADDIN EN.CITE.DATA [256-258] and is likely indicated with the extended release tablets that may achieve high drug concentrations and be associated with increased toxicities.Isavuconazole Isavuconazonium sulfate (referred to in these guidelines as isavuconazole) is a prodrug containing the active antifungal agent isavuconazole, a broad-spectrum triazole agent with a 5-day half-life ADDIN EN.CITE <EndNote><Cite><Author>Miceli</Author><Year>2015</Year><RecNum>700</RecNum><DisplayText>[259]</DisplayText><record><rec-number>700</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1445556730">700</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Miceli, M. H.</author><author>Kauffman, C. A.</author></authors></contributors><auth-address>Division of Infectious Diseases, Department of Internal Medicine, University of Michigan Health System.&#xD;Division of Infectious Diseases, Department of Internal Medicine, University of Michigan Health System Veterans Affairs Ann Arbor Healthcare System, Michigan.</auth-address><titles><title>Isavuconazole: A New Broad-Spectrum Triazole Antifungal Agent</title><secondary-title>Clin Infect Dis</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>1558-65</pages><volume>61</volume><number>10</number><keywords><keyword>aspergillosis</keyword><keyword>isavuconazole</keyword><keyword>isavuconazonium sulfate</keyword><keyword>mucormycosis</keyword><keyword>triazoles</keyword></keywords><dates><year>2015</year><pub-dates><date>Jul 15</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>26179012</accession-num><urls><related-urls><url>;[259]. The intravenous formulation does not contain cyclodextrin and as do other triazoles. Isavuconazole requires a loading dose. The toxicity profile is similar to that of other triazoles with a similar rate of gastrointestinal disorders, but based on limited experience, a lower rate of photosensitivity and skin disorders, hepatobiliary and visual disturbances as compared with voriconazole PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GYWxjaTwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [260, 261]. Significant interactions with drugs metabolized by cytochrome P450 are expected to occur, especially with substrates and inducers of the CYP3A4 enzyme although preclinical studies suggest these drug interactions are less severe than with voriconazole. Coadministration of methotrexate with isavuconazole increases exposure to 7-OH methotrexate, a potentially toxic metabolite. Tacrolimus and sirolimus levels are likely to be increased by coadministration of isavuconazole while interactions with cyclosporine and glucocorticoids appear modest. Interestingly, in contrast to other triazoles, isavuconazole could shorten the QTc interval; the clinical significance of this is unclear. There is no effect of the polymorphisms of CYP2C19, which contributes to considerable interpatient variability in serum concentrations of voriconazole. Triazole Drug Interactions and Therapeutic Drug MonitoringRecommendations21.For patients receiving triazole-based therapy for IA, prolonged azole prophylaxis, or other therapies for which drug interactions with azoles are anticipated, the committee recommends TDM once the steady state has been reached. A moderate amount of data for itraconazole, voriconazole, and posaconazole suspension suggests this approach may be valuable in enhancing therapeutic efficacy, in evaluating therapeutic failures attributable to suboptimal drug exposures, and to minimize toxicities potentially attributable to the azoles. (Strong Recommendation; Moderate Quality Evidence). Further studies are needed to address whether TDM is helpful or necessary with the extended release or intravenous formulations of posaconazole or for isavuconazole.22.Clinicians should obtain serum trough drug levels for azole antifungal agents (itraconazole, voriconazole, posaconazole, and possibly isavuconazole) and for potentially interacting drugs such as cyclosporine, tacrolimus, and sirolimus (and other CYP450 3A4 substrates such as tyrosine kinase inhibitors) to optimize therapeutic efficacy and to avoid potential toxicities of both groups of agents (Strong Recommendation; Moderate Quality Evidence). Evidence SummaryDespite a lack of definitive data from large clinical studies, TDM is increasingly recognized as a useful tool for optimizing the safety and efficacy of azole antifungals. Generally, an antifungal agent must meet three general criteria for antifungal TDM to be clinically useful. First, a sensitive assay must be available locally or in a reference laboratory that will report results back in a timely fashion (within days), otherwise the impact of monitoring on clinical decision-making will be limited. Second, the antifungal must have an established therapeutic range, such that treatment success can be improved or toxicity potentially reduced if patients are dosed to maintain concentrations within this therapeutic window. Finally, the drug must have significant intra- or inter-patient pharmacokinetic variability, such that variations in serum levels may jeopardize the effectiveness of therapy with standard dosing guidelines.Triazole antifungal agents contribute to various important toxicities and drug-drug interactions which may limit therapy (Table 3). Many of the drug interactions are class-related while common toxicities are often specific to the dose or duration of therapy with individual agents PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CcnVnZ2VtYW5uPC9BdXRob3I+PFllYXI+MjAwOTwvWWVh

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ADDIN EN.CITE.DATA [262, 263]. The triazoles are metabolic substrates for, and inhibitors of, several CYP450 enzymes and inhibitors of the p-gp membrane transporter ADDIN EN.CITE <EndNote><Cite><Author>Ashbee</Author><Year>2012</Year><RecNum>875</RecNum><DisplayText>[264]</DisplayText><record><rec-number>875</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454445933">875</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ashbee, H. R.</author><author>Gilleece, M. H.</author></authors></contributors><auth-address>Mycology Reference Centre, Department of Microbiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK. h.r.ashbee@leeds.ac.uk</auth-address><titles><title>Has the era of individualised medicine arrived for antifungals? A review of antifungal pharmacogenomics</title><secondary-title>Bone Marrow Transplant</secondary-title></titles><periodical><full-title>Bone Marrow Transplantation</full-title><abbr-1>Bone Marrow Transplant.</abbr-1><abbr-2>Bone Marrow Transplant</abbr-2></periodical><pages>881-94</pages><volume>47</volume><number>7</number><keywords><keyword>Antifungal Agents/*pharmacokinetics/*therapeutic use</keyword><keyword>Drug Interactions</keyword><keyword>Humans</keyword><keyword>Mycoses/*drug therapy/*genetics/metabolism</keyword><keyword>Pharmacogenetics/*methods</keyword><keyword>Precision Medicine/*methods</keyword></keywords><dates><year>2012</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1476-5365 (Electronic)&#xD;0268-3369 (Linking)</isbn><accession-num>21785468</accession-num><urls><related-urls><url>;[264]. Polymorphisms are common in the genes encoding these P450 isoenzymes, particularly CYP2C19, and others with less prominent roles in triazole pharmacokinetics ADDIN EN.CITE <EndNote><Cite><Author>Dvorak</Author><Year>2011</Year><RecNum>876</RecNum><DisplayText>[265]</DisplayText><record><rec-number>876</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454445974">876</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dvorak, Z.</author></authors></contributors><auth-address>Department of Cell Biology and Genetics, Faculty of Science, Palacky University, Slechtitelu 11, 783 71 Olomouc, Czech Republic. moulin@email.cz</auth-address><titles><title>Drug-drug interactions by azole antifungals: Beyond a dogma of CYP3A4 enzyme activity inhibition</title><secondary-title>Toxicol Lett</secondary-title></titles><periodical><full-title>Toxicology Letters</full-title><abbr-1>Toxicol. Lett.</abbr-1><abbr-2>Toxicol Lett</abbr-2></periodical><pages>129-32</pages><volume>202</volume><number>2</number><keywords><keyword>Antifungal Agents/*pharmacology</keyword><keyword>Azoles/*pharmacology</keyword><keyword>Cytochrome P-450 CYP3A/*metabolism</keyword><keyword>*Cytochrome P-450 CYP3A Inhibitors</keyword><keyword>Drug Interactions</keyword><keyword>Enzyme Activation</keyword><keyword>Humans</keyword><keyword>Receptors, Glucocorticoid/metabolism</keyword><keyword>Receptors, Steroid/metabolism</keyword></keywords><dates><year>2011</year><pub-dates><date>Apr 25</date></pub-dates></dates><isbn>1879-3169 (Electronic)&#xD;0378-4274 (Linking)</isbn><accession-num>21333771</accession-num><urls><related-urls><url>;[265]. The polymorphisms of CYP3A4 are not considered to contribute significantly to differences in human metabolism of antifungal triazoles ADDIN EN.CITE <EndNote><Cite><Author>Meletiadis</Author><Year>2006</Year><RecNum>514</RecNum><DisplayText>[266]</DisplayText><record><rec-number>514</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1432752492">514</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Meletiadis, J.</author><author>Chanock, S.</author><author>Walsh, T. J.</author></authors></contributors><auth-address>Pediatric Oncology Branch, National Cancer Institute, CRC, 1-5750 10 Center Drive, Bethesda, MD 20892, USA.</auth-address><titles><title>Human pharmacogenomic variations and their implications for antifungal efficacy</title><secondary-title>Clin Microbiol Rev</secondary-title><alt-title>Clinical microbiology reviews</alt-title></titles><periodical><full-title>Clinical Microbiology Reviews</full-title><abbr-1>Clin. Microbiol. Rev.</abbr-1><abbr-2>Clin Microbiol Rev</abbr-2></periodical><alt-periodical><full-title>Clinical Microbiology Reviews</full-title><abbr-1>Clin. Microbiol. Rev.</abbr-1><abbr-2>Clin Microbiol Rev</abbr-2></alt-periodical><pages>763-87</pages><volume>19</volume><number>4</number><keywords><keyword>Antifungal Agents/*pharmacokinetics/therapeutic use</keyword><keyword>Drug Therapy</keyword><keyword>Genetic Variation</keyword><keyword>*Genome, Human</keyword><keyword>Humans</keyword><keyword>Intestinal Absorption/physiology</keyword><keyword>Pharmacogenetics/*methods</keyword><keyword>*Polymorphism, Genetic</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2006</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>0893-8512 (Print)&#xD;0893-8512 (Linking)</isbn><accession-num>17041143</accession-num><urls><related-urls><url>;[266]. The polymorphisms of CYP2C19 are a common cause for substantial inter-patient variability in drug levels in patients receiving voriconazole. The triazole antifungal agents demonstrate significant drug-drug interactions that may adversely affect patient outcomes ADDIN EN.CITE <EndNote><Cite><Author>Gubbins</Author><Year>2011</Year><RecNum>874</RecNum><DisplayText>[263]</DisplayText><record><rec-number>874</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454445777">874</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gubbins, P. O.</author></authors></contributors><auth-address>University of Arkansas for Medical Sciences, College of Pharmacy , Department of Pharmacy Practice, Little Rock, AR 72205, USA. gubbinspaulo@uams.edu</auth-address><titles><title>Triazole antifungal agents drug-drug interactions involving hepatic cytochrome P450</title><secondary-title>Expert Opin Drug Metab Toxicol</secondary-title></titles><periodical><full-title>Expert Opinion on Drug Metabolism &amp; Toxicology</full-title><abbr-1>Expert Opin. Drug Metab. Toxicol.</abbr-1><abbr-2>Expert Opin Drug Metab Toxicol</abbr-2></periodical><pages>1411-29</pages><volume>7</volume><number>11</number><keywords><keyword>Antifungal Agents/adverse effects/*metabolism/therapeutic use</keyword><keyword>Cytochrome P-450 Enzyme System/genetics/*metabolism</keyword><keyword>Drug Interactions</keyword><keyword>Humans</keyword><keyword>Mycoses/*drug therapy</keyword><keyword>Triazoles/adverse effects/*metabolism/therapeutic use</keyword></keywords><dates><year>2011</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1744-7607 (Electronic)&#xD;1742-5255 (Linking)</isbn><accession-num>21995615</accession-num><urls><related-urls><url>;[263]. Each patient’s current medications should be reviewed for potentially deleterious drug interactions. 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ADDIN EN.CITE.DATA [262, 267-282]. All of the azoles have important interactions via the CYP450 enzymes, notably CYP3A4. Active transporters including the p-gp and the breast cancer resistance protein (BCRP) regulate access of the azoles to the drug-metabolizing enzymes of enterocytes and the liver; the clinical importance of the transporters remains to be further defined PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYW5nPC9BdXRob3I+PFllYXI+MjAwMjwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [285, 286]. There is general agreement that documentation of adequate (and in the case of voriconazole, non-toxic) serum levels in the first 4-7 days after starting therapy (when a patient is at a pharmacokinetic steady-state) is preferable for any patient with suspected or documented aspergillosis. Less agreement exists whether TDM is necessary during primary triazole prophylaxis, but low plasma levels of itraconazole and posaconazole suspension have been associated with higher probability of breakthrough infection and limited data suggested high levels of posaconazole may be associated with toxicity ADDIN EN.CITE <EndNote><Cite><Author>Lerolle</Author><Year>2014</Year><RecNum>177</RecNum><DisplayText>[287]</DisplayText><record><rec-number>177</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412206429">177</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lerolle, N.</author><author>Raffoux, E.</author><author>Socie, G.</author><author>Touratier, S.</author><author>Sauvageon, H.</author><author>Porcher, R.</author><author>Bretagne, S.</author><author>Bergeron, A.</author><author>Azoulay, E.</author><author>Molina, J. M.</author><author>Lafaurie, M.</author></authors></contributors><auth-address>Infectious Diseases Intervention Unit, Hopital Saint-Louis, APHP, University of Paris Diderot Paris 7, Paris, France.</auth-address><titles><title>Breakthrough invasive fungal disease in patients receiving posaconazole primary prophylaxis: a 4-year study</title><secondary-title>Clin Microbiol Infect</secondary-title><alt-title>Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases</alt-title></titles><periodical><full-title>Clinical Microbiology and Infection</full-title><abbr-1>Clin. Microbiol. Infect.</abbr-1><abbr-2>Clin Microbiol Infect</abbr-2><abbr-3>Clinical Microbiology &amp; Infection</abbr-3></periodical><dates><year>2014</year><pub-dates><date>May 26</date></pub-dates></dates><isbn>1469-0691 (Electronic)&#xD;1198-743X (Linking)</isbn><accession-num>24861577</accession-num><urls><related-urls><url>;[287]. The need for continued or repeat monitoring is a patient-specific decision influenced by the clinical status of the host (e.g., specific organ function, co- morbidities, and receipt of concomitant medications), severity of infection, concerns regarding non-adherence, cost, TDM assay availability, possibly the duration of therapy ADDIN EN.CITE <EndNote><Cite><Author>Mulanovich</Author><Year>2007</Year><RecNum>489</RecNum><DisplayText>[288]</DisplayText><record><rec-number>489</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1428431985">489</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mulanovich, V.</author><author>Lewis, R. E.</author><author>Raad,, II</author><author>Kontoyiannis, D. P.</author></authors></contributors><auth-address>Department of Infectious Diseases, Infection Control and Employee Health, Unit 402, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA.</auth-address><titles><title>Random plasma concentrations of voriconazole decline over time</title><secondary-title>J Infect</secondary-title><alt-title>The Journal of infection</alt-title></titles><periodical><full-title>Journal of Infection</full-title><abbr-1>J. Infect.</abbr-1><abbr-2>J Infect</abbr-2></periodical><pages>e129-30</pages><volume>55</volume><number>5</number><keywords><keyword>Antifungal Agents/blood/*pharmacokinetics/therapeutic use</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Neoplasms/complications</keyword><keyword>Plasma/*chemistry</keyword><keyword>Pyrimidines/blood/*pharmacokinetics/therapeutic use</keyword><keyword>Retrospective Studies</keyword><keyword>Time Factors</keyword><keyword>Triazoles/blood/*pharmacokinetics/therapeutic use</keyword><keyword>Voriconazole</keyword></keywords><dates><year>2007</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1532-2742 (Electronic)&#xD;0163-4453 (Linking)</isbn><accession-num>17804077</accession-num><urls><related-urls><url>;[288], and the overall treatment plan. Determination of a plasma drug level, in conjunction with other measures of clinical assessment, can help define factors that may have led to therapeutic failure with oral triazoles and reopen prospects for use of the same oral drug in the future provided pharmacokinetic issues are corrected. Overviews of clinical scenarios that frequently justify TDM are presented in Table 2. The therapeutic range for voriconazole and posaconazole have been primarily defined from single center, retrospective studies and can only be considered a general guide for dosing ADDIN EN.CITE <EndNote><Cite><Author>Ashbee</Author><Year>2014</Year><RecNum>156</RecNum><DisplayText>[286]</DisplayText><record><rec-number>156</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412202621">156</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ashbee, H. R.</author><author>Barnes, R. A.</author><author>Johnson, E. M.</author><author>Richardson, M. D.</author><author>Gorton, R.</author><author>Hope, W. W.</author></authors></contributors><auth-address>Mycology Reference Centre, Department of Microbiology, Leeds Teaching Hospitals NHS Trust, Leeds LS1 3EX, UK.</auth-address><titles><title>Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology</title><secondary-title>J Antimicrob Chemother</secondary-title><alt-title>The Journal of antimicrobial chemotherapy</alt-title></titles><periodical><full-title>Journal of Antimicrobial Chemotherapy</full-title><abbr-1>J. Antimicrob. Chemother.</abbr-1><abbr-2>J Antimicrob Chemother</abbr-2></periodical><pages>1162-76</pages><volume>69</volume><number>5</number><dates><year>2014</year><pub-dates><date>May</date></pub-dates></dates><isbn>1460-2091 (Electronic)&#xD;0305-7453 (Linking)</isbn><accession-num>24379304</accession-num><urls><related-urls><url>;[286]. ItraconazoleItraconazole capsules require low gastric pH for dissolution, and are therefore poorly absorbed in many patient populations with relative achlorhydria associated with their underlying disease or pharmacotherapy. Itraconazole suspension is better absorbed, but is associated with higher gastrointestinal adverse effects, which are especially problematic in populations who already have nausea, vomiting or diarrhea. Although a variable rate of breakthrough IA has been reported in patients on itraconazole prophylaxis, relatively few studies have examined the relationship of itraconazole plasma concentrations and treatment efficacy for aspergillosis. Based primarily on prophylaxis data, most experts recommend dosing itraconazole to achieve trough concentrations greater than 0.5-1 ?g/mL (combined itraconazole/hydroxyitraconazole troughs >1.5 ?g/mL). 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ADDIN EN.CITE.DATA [289]. Voriconazole Various target concentrations associated with voriconazole efficacy have been reported, mostly from single institution retrospective studies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2x0b248L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [216, 285]. Most experts would aim for dosing to achieve a voriconazole trough of greater than 1-1.5 ?g/mL for efficacy but less than?5-6 ?g/mL to minimize toxicity, primarily CNS toxicity. Visual changes can be related to elevated voriconazole concentration but generally resolve spontaneously and without long-term sequelae. Although voriconazole trough concentrations can be elevated in patients with hepatic dysfunction, available data do not support the concept of a threshold level that could adequately discriminate who will be at higher risk for hepatotoxicity PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UYW48L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFyPjxSZWNO

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ADDIN EN.CITE.DATA [231]. In a prospective, randomized blinded single center trial of TDM during voriconazole therapy in 100 patients, the proportion of voriconazole discontinuation due to adverse events was signi?cantly lower in the TDM group than in the non-TDM group (4% vs 17%; P= 0.02) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXJrPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [290]. More importantly, higher rates of complete or partial response were observed in patients managed with TDM (81% versus those without TDM 57%; P= 0.04). This study and several others suggest that antifungal TDM may reduce drug discontinuation due to adverse events and improve the likelihood of a therapeutic response. There are no widely-validated algorithms on how to dose voriconazole. Weight-based dosing is recommended to rapidly achieve therapeutic range, with incremental increases and monitoring (i.e. 50% increase in daily dose) for the patient who has trough levels <1 ?g/mL. Voriconazole concentrations often increase disproportionately to administered doses due to saturable metabolism in adults. For patients with very low voriconazole levels, co-administering omeprazole (a CYP 2C19 inhibitor) has been reported to “boost” voriconazole AUCs by 41% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3lkPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [291]. Fundamental pharmacokinetics of voriconazole are different in children (linear) than in adults (non-linear) ADDIN EN.CITE <EndNote><Cite><Author>Walsh</Author><Year>2004</Year><RecNum>936</RecNum><DisplayText>[292]</DisplayText><record><rec-number>936</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">936</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Walsh, T J</author><author>Karlsson, M O</author><author>Driscoll, T</author><author>Arguedas, A G</author><author>Adamson, P</author><author>Saez-Llorens, X</author><author>Vora, A J</author><author>Arrieta, A C</author><author>Blumer, J</author><author>Lutsar, I</author><author>Milligan, P</author><author>Wood, N</author></authors></contributors><titles><title>Pharmacokinetics and safety of intravenous voriconazole in children after single- or multiple-dose administration</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>2166-2172</pages><volume>48</volume><dates><year>2004</year></dates><urls></urls></record></Cite></EndNote>[292]. In pediatric patients weighing <50 kg higher voriconazole doses are needed ADDIN EN.CITE <EndNote><Cite><Author>Pascual</Author><Year>2012</Year><RecNum>1063</RecNum><DisplayText>[293]</DisplayText><record><rec-number>1063</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1063</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pascual, A</author><author>Csajka, C</author><author>Buclin, T</author><author>Bolay, S</author><author>Bille, J</author><author>Calandra, T</author><author>Marchetti, O</author></authors></contributors><titles><title>Challenging recommended oral and intravenous voriconazole doses for improved efficacy and safety: population pharmacokinetics-based analysis of adult patients with invasive fungal infections</title><secondary-title>Clinical Infectious Diseases</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin Infect Dis</abbr-1></periodical><pages>381-90</pages><volume>55</volume><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>[293] and drug monitoring is paramount (see specific evidence discussion following Recommendation 45 below). PosaconazoleIncreasing evidence supports an exposure-response relationship for plasma posaconazole concentrations for prophylaxis and treatment of invasive fungal infections (IFIs) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb2x0b248L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [1], makes prudent a strategy of monitoring posaconazole serum concentrations in patients with IA who are on chronic posaconazole suspension. On the other hand, a clear relationship has not been identified between posaconazole concentrations and the risk of breakthrough IA in the pivotal posaconazole registration trials PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3JuZWx5PC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48

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ADDIN EN.CITE.DATA [246, 295, 296]. Further studies are needed to address whether higher posaconazole levels are associated with toxicity and whether TDM is helpful or necessary with the extended release or intravenous formulations. The value of TDM to guide therapy and to avoid toxicity for isavuconazole, a once daily extended-spectrum triazole with anti-Aspergillus activity with good absorption kinetics, similarly remains to be assessed ADDIN EN.CITE <EndNote><Cite><Author>Falci</Author><Year>2013</Year><RecNum>164</RecNum><DisplayText>[260]</DisplayText><record><rec-number>164</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412203374">164</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Falci, D. R.</author><author>Pasqualotto, A. C.</author></authors></contributors><auth-address>Hospital Nossa Senhora da Conceicao, Porto Alegre, Brazil ; Universidade Federal de Ciencias da Saude de Porto Alegre, Porto Alegre, Brazil.</auth-address><titles><title>Profile of isavuconazole and its potential in the treatment of severe invasive fungal infections</title><secondary-title>Infect Drug Resist</secondary-title><alt-title>Infection and drug resistance</alt-title></titles><periodical><full-title>Infect Drug Resist</full-title></periodical><pages>163-74</pages><volume>6</volume><dates><year>2013</year></dates><isbn>1178-6973 (Electronic)&#xD;1178-6973 (Linking)</isbn><accession-num>24187505</accession-num><urls><related-urls><url>;[260]. Preclinical and Laboratory Assessment of Combination antifungal binations of polyenes or azoles with echinocandins suggest additive or synergistic effects in some pre-clinical studies.? However, variable test designs and conflicting results of preclinical and in vitro testing have led to uncertainty as to how to interpret the findings.? (Weak Recommendation; Low Quality Evidence).Evidence summaryThe rationale for combination therapy is to maximize treatment by targeting multiple targets or metabolic pathways or different points in the same pathway to improve efficacy through achieving an additive or synergistic effect. Other potential benefits include lowering the risk for emergence of drug resistance and the potential for shorter courses of therapy or lower doses of therapy in an attempt to reduce toxicity. Antifungal drug combinations have been evaluated in multiple in vitro studies and studied in animal models. Combinations of polyenes or azoles with echinocandins have been most studied and additive or synergistic effects have been noted in the majority of (but not all) studies when compared to monotherapy (especially echinocandins alone) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NdWtoZXJqZWU8L0F1dGhvcj48WWVhcj4yMDA1PC9ZZWFy

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ADDIN EN.CITE.DATA [297-301]. Unfortunately, there are no standardized or validated protocols for in vitro synergy testing, and there are substantive differences in study design, laboratory assay conditions, definitions of endpoints, species and strains tested, animal model differences, drug choice and concentrations/doses, drug monotherapy comparator, inoculation size, and portal of pathogen administration. Further, correlation between in vitro findings and in vivo observations have not always been consistent and differences in drug metabolism between animals and humans make comparisons difficult. Also, of importance is the order of administration. Some studies have suggested prior azole administration subsequently reduced polyene activity PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2hhZmZuZXI8L0F1dGhvcj48WWVhcj4xOTg1PC9ZZWFy

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ADDIN EN.CITE.DATA [302-309]. Antagonism during the use of combination therapy has also been suggested by some studies, especially between polyenes and certain azoles PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NZWxldGlhZGlzPC9BdXRob3I+PFllYXI+MjAwNjwvWWVh

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Tm90ZT4A

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Tm90ZT4A

ADDIN EN.CITE.DATA [310]. By comparison the combination of triazole and echinocandin agents exhibit synergistic to additive interactions in the same systems PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZXRyYWl0aXM8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFy

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ADDIN EN.CITE.DATA [311]. However, a murine model demonstrated possible antagonism between itraconazole and micafungin PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGVtb25zPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [312]. In vitro studies demonstrate that the combination of triazole and polyene may be antagonistic PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DbGVtb25zPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [311, 313]. In addition to reduced antifungal activity, other potential harmful effects may include increased risk for resistance, additive toxicity, cost, and deleterious drug interactions. Although the preclinical studies have been generally favorable to consideration of combinations of mould-active azoles or polyenes with echinocandins, the variable test designs and conflicting results of preclinical testing have led to uncertainty as to the applicability to clinical practice.When should antifungal susceptibility testing be performed and how should results be interpreted and affect management?Recommendation24.Routine antifungal susceptibility testing of isolates recovered during initial infection is not recommended. Antifungal susceptibility testing of Aspergillus isolates using a reference method is reserved for patients suspected to have an azole resistant isolate, who are unresponsive to antifungal agents, or for epidemiological purposes (Strong Recommendation; Moderate Quality Evidence).Evidence summaryThe goal of antifungal susceptibility testing (AFST) is to detect resistant isolates that are more likely to fail therapy in patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WZXJ3ZWlqPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48

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ADDIN EN.CITE.DATA [314, 315]. Considerable progress since the previous guideline has occurred toward achieving this goal. The European Committee on Antibiotic Susceptibility Testing (EUCAST) and the Clinical Laboratory Standards Institute (CLSI) have published standardized but different AFST methodologies in recent years PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdWJjb21taXR0ZWUgb24gQW50aWZ1bmdhbCBTdXNjZXB0

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PjwvRW5kTm90ZT5=

ADDIN EN.CITE.DATA [316, 317]. Aspergillus MICs utilizing EUCAST and CLSI methodologies from more recent clinical studies and large surveys have been determined. Although clinical breakpoints are not yet defined by CLSI, epidemiological cutoff values (ECVs)—the upper limit of wild-type MIC distributions which aid in the determining the likelihood of resistance in Aspergillus spp.—have been proposed by CLSI. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DdWVuY2EtRXN0cmVsbGE8L0F1dGhvcj48WWVhcj4yMDAz

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ADDIN EN.CITE.DATA [318-321]. Establishing ECVs for azoles and A. fumigatus, utilizing in vitro pharmacokinetic and pharmacodynamic (PK/PD) studies, in vivo correlation of mutations and failure, and clinical experience aided derivation of proposed azole clinical breakpoints by EUCASTPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HZW9yZ2lhZG91PC9BdXRob3I+PFllYXI+MjAxMjwvWWVh

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ADDIN EN.CITE.DATA [325].The advances of molecular techniques have led to important changes to Aspergillus taxonomy contributed to by the phylogenetic species recognition (PSR) concept ADDIN EN.CITE <EndNote><Cite><Author>Taylor</Author><Year>2000</Year><RecNum>906</RecNum><DisplayText>[327]</DisplayText><record><rec-number>906</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454447945">906</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Taylor, J. W.</author><author>Jacobson, D. J.</author><author>Kroken, S.</author><author>Kasuga, T.</author><author>Geiser, D. M.</author><author>Hibbett, D. S.</author><author>Fisher, M. C.</author></authors></contributors><auth-address>Department of Plant and Microbial Biology, University of California, Berkeley, California 94720-3102, USA.</auth-address><titles><title>Phylogenetic species recognition and species concepts in fungi</title><secondary-title>Fungal Genet Biol</secondary-title></titles><periodical><full-title>Fungal Genetics and Biology</full-title><abbr-1>Fungal Genet. Biol.</abbr-1><abbr-2>Fungal Genet Biol</abbr-2><abbr-3>Fungal Genetics &amp; Biology</abbr-3></periodical><pages>21-32</pages><volume>31</volume><number>1</number><keywords><keyword>Evolution, Molecular</keyword><keyword>Fungi/*classification/genetics/physiology</keyword><keyword>*Phylogeny</keyword><keyword>Species Specificity</keyword></keywords><dates><year>2000</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1087-1845 (Print)&#xD;1087-1845 (Linking)</isbn><accession-num>11118132</accession-num><urls><related-urls><url>;[327]. The PSR method based on sequencing of several targets for species recognition analysis has identified new cryptic species, some of which are more resistant to current antifungal drugs ADDIN EN.CITE <EndNote><Cite><Author>Alastruey-Izquierdo</Author><Year>2014</Year><RecNum>2</RecNum><DisplayText>[328]</DisplayText><record><rec-number>2</rec-number><foreign-keys><key app="EN" db-id="f0r2ftpwrdtaeqef5fr5wwa4929wppveprxr" timestamp="1405972990">2</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Alastruey-Izquierdo, A.</author><author>Alcazar-Fuoli, L.</author><author>Cuenca-Estrella, M.</author></authors></contributors><auth-address>Mycology Reference Laboratory, National Centre for Microbiology, Spanish Network for the Research in Infectious Diseases (REIPI RD12/0015), Instituto de Salud Carlos III, Majadahonda, Madrid, Spain, anaalastruey@isciii.es.</auth-address><titles><title>Antifungal Susceptibility Profile of Cryptic Species of Aspergillus</title><secondary-title>Mycopathologia</secondary-title><alt-title>Mycopathologia</alt-title></titles><periodical><full-title>Mycopathologia</full-title><abbr-1>Mycopathologia</abbr-1></periodical><alt-periodical><full-title>Mycopathologia</full-title><abbr-1>Mycopathologia</abbr-1></alt-periodical><edition>2014/06/29</edition><dates><year>2014</year><pub-dates><date>Jun 28</date></pub-dates></dates><isbn>0301-486x</isbn><accession-num>24972670</accession-num><urls></urls><electronic-resource-num>10.1007/s11046-014-9775-z</electronic-resource-num><remote-database-provider>Nlm</remote-database-provider><language>Eng</language></record></Cite></EndNote>[328]. Azole resistance in filamentous fungi primarily involves mutations in the CYP51A target enzyme that lead to specific or pan-azole resistance, and is described more frequently in A. fumigatus complex than other spp. PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGVuPC9BdXRob3I+PFllYXI+MjAwNTwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [329-335]. Other azole resistance mechanisms are also described PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbGJhcnJhZzwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+

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ADDIN EN.CITE.DATA [336-341]. Resistance to the echinocandins is uncommon, as is resistance to AmB apart from A. terreus, A. nidulans, and A. lentulus PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcmVuZHJ1cDwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+

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ADDIN EN.CITE.DATA [348, 349]. At this time, AFST is not routinely performed in most clinical laboratories in the U.S. Molecular methods to identify azole and echinocandin resistance in filamentous fungi are under investigation but not yet standardized or validated and require further study ADDIN EN.CITE <EndNote><Cite><Author>Cuenca-Estrella</Author><Year>2014</Year><RecNum>919</RecNum><DisplayText>[343]</DisplayText><record><rec-number>919</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454448566">919</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Cuenca-Estrella, M.</author></authors></contributors><auth-address>National Center for Microbiology, Instituto de Salud Carlos III, Madrid, Spain.</auth-address><titles><title>Antifungal drug resistance mechanisms in pathogenic fungi: from bench to bedside</title><secondary-title>Clin Microbiol Infect</secondary-title></titles><periodical><full-title>Clinical Microbiology and Infection</full-title><abbr-1>Clin. Microbiol. Infect.</abbr-1><abbr-2>Clin Microbiol Infect</abbr-2><abbr-3>Clinical Microbiology &amp; Infection</abbr-3></periodical><pages>54-9</pages><volume>20 Suppl 6</volume><keywords><keyword>Amphotericin B/pharmacology</keyword><keyword>Antifungal Agents/*pharmacology/therapeutic use</keyword><keyword>Azoles/pharmacology</keyword><keyword>*Drug Resistance, Fungal</keyword><keyword>Echinocandins/pharmacology</keyword><keyword>Fungi/*drug effects</keyword><keyword>Humans</keyword><keyword>Microbial Sensitivity Tests</keyword><keyword>Mycoses/diagnosis/drug therapy/*microbiology</keyword><keyword>Aspergillus</keyword><keyword>Candida</keyword><keyword>mutations</keyword><keyword>mycosis</keyword><keyword>tandem repeat</keyword></keywords><dates><year>2014</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1469-0691 (Electronic)&#xD;1198-743X (Linking)</isbn><accession-num>24372680</accession-num><urls><related-urls><url>;[343]. However, in the case of isolates with atypical growth or concerns for resistance when molecular methods are not available, AFST should be employed. In conclusion, AFST advances in the past decade are significant, however worldwide Aspergillus resistance remains low, and routine AFST for clinical management is not recommended at this time.INVASIVE SYNDROMES OF ASPERGILLUSIV. What are the recommended treatment regimens and adjunctive treatment measures for the various clinical presentations of IA?How should IPA be treated?Recommendations25.We recommend primary treatment with voriconazole (Strong Recommendation; High Quality Evidence). 26.Early initiation of antifungal therapy in patients with strongly suspected IPA is warranted while a diagnostic evaluation is conducted (Strong Recommendation; High Quality Evidence)27.Alternative therapies include liposomal AmB (Strong Recommendation; Moderate Quality Evidence), isavuconazole (Strong Recommendation; Moderate Quality Evidence), or other lipid formulations of AmB (Weak Recommendation; Low Quality Evidence). bination antifungal therapy with voriconazole and an echinocandin may be considered in select patients with documented IPA (Weak Recommendation; Moderate Quality Evidence)29.Primary therapy with an echinocandin is not recommended (Strong Recommendation; Moderate Quality Evidence). Echinocandins (micafungin or caspofungin) can be used in settings in which azole and polyene antifungals are contraindicated (Weak Recommendation; Moderate Quality Evidence).30.We recommend that treatment of IPA be continued for a minimum of 6-12 weeks, largely dependent on the degree and duration of immunosuppression, site of disease, and evidence of disease improvement (Strong Recommendation; Low Quality Evidence). 31.For patients with successfully treated IPA who require subsequent immunosuppression, secondary prophylaxis should be initiated to prevent recurrence (Strong Recommendation; Moderate Quality Evidence). Evidence summaryEarly initiation of antifungal therapy in patients with strongly suspected IPA is warranted while a diagnostic evaluation is conducted, both because early therapy has been shown to limit progression of disease and because the performance of diagnostic testing remains limited PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmVlbmU8L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [147, 177]. Availability of drugs that have differential activity for moulds that cause similar syndromes, specifically, the lack of voriconazole activity against mucormycosis, emphasizes the importance of a specific microbiologic diagnosis and antimicrobial susceptibility testing. Evidence supporting appropriate primary therapy of IPA has been generated in a series of randomized controlled trials. The first pivotal treatment trial performed for invasive aspergillosis demonstrated better survival in patients who received voriconazole compared to AmB deoxycholate PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZXJicmVjaHQ8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFy

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ADDIN EN.CITE.DATA [350], justifying a recommendation against AmB deoxycholate therapy. Since that original randomized trial, multiple cohort studies subsequently published support this recommendation with ~15% improved survival at 12 weeks in all patient types with voriconazole compared with other intravenous therapies. Thus, for primary treatment of IPA in adults, IV or oral voriconazole is recommended for most patients. For seriously ill patients, the parenteral formulation is recommended. A switch to oral therapy, with dosing maximized to achieve recommended target serum levels, can be considered in patients who are able to tolerate oral therapy. A randomized trial compared voriconazole with isavuconazole, which demonstrated non-inferiority in treatment of IPA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWVydGVuczwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+

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ADDIN EN.CITE.DATA [351]. This study showed non-inferiority in terms of clinical efficacy, measured by survival and composite clinical responses in the intent-to-treat population of patients with possible, probable and proven aspergillosis. There were fewer drug-related adverse effects in people who received isavuconazole. Based on these data, isavuconazole was approved by the FDA for first line therapy of IA and is recommended as an alternative primary therapy for IPA.Another alternative for primary therapy of IA is liposomal AmB. Although no randomized trial has been performed to evaluate effectiveness of this drug compared to voriconazole for primary therapy, a series of randomized trials suggest effectiveness in therapy. Randomized trials of variable quality evaluating primary treatment of IA using lipid formulations of AmB have been reported to generally favor outcomes with lipid formulations, especially with regards to minimizing toxicities. The most compelling effectiveness data have been generated from randomized trials evaluating liposomal AmB. Cornely et al PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3JuZWx5PC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48

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ADDIN EN.CITE.DATA [177] compared an initial dosage of liposomal AmB of 10 mg/kg/day for 2 weeks with a dosage of 3 mg/kg/day. In that study, among 201 patients, overall outcomes in the 2 arms were similar (46% in the high-dose arm vs. 50% in the low-dose arm), but there was more toxicity (32% vs. 20%) in the high-dose arm, suggesting that higher doses were not beneficial. These results suggest that liposomal AmB be considered as alternative primary therapy in some patients, especially in situations in which hepatic toxicities or drug interactions warrant non-azole alternatives, and when voriconazole-resistant moulds (e.g. mucormycosis) remain of concern. Another lipid AmB alternative is ABLC (5mg/kg/day), which has not been studied in randomized trials for IA, but has been reported to be effective in observational studies, particularly in the setting of salvage infection, and is generally well-tolerated compared to AmB deoxycholate PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYWNoZW08L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [352-355].Finally, ABCD was compared to AmB deoxycholate in a randomized trial of 174 patients. Although therapeutic responses were similar (52 vs 51%), infusion related reactions were more common in ABCD. ?Renal toxicity occurred less frequently with ABCD PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3dkZW48L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [176], but due to an increase in serious drug reactions, principally fever, chills and hypoxia, use of ABCD is not bination therapy in the treatment of IPA has been supported by generally favorable in vitro and in vivo preclinical data in support of combinations of polyenes or mould-active azoles with echinocandins. Nonrandomized clinical trial data suggest the benefit of some forms of combination therapy against IA, usually an azole (most commonly voriconazole) with an echinocandins in aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWVydGVuczwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+

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ADDIN EN.CITE.DATA [363], 30 hematologic malignancy patients with proven or probable IA were randomized to either a standard dose of liposomal AmB (3 mg/kg/d) plus caspofungin or high dose liposomal AmB alone (10 mg/kg/d). Responses were better at the end of therapy with combination therapy but overall survival was similar. A more recent randomized trial compared outcomes of voriconazole monotherapy to combination therapy with voriconazole plus anidulafungin ADDIN EN.CITE <EndNote><Cite><Author>Marr</Author><Year>2015</Year><RecNum>429</RecNum><DisplayText>[364]</DisplayText><record><rec-number>429</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1423268317">429</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Marr, K. A.</author><author>Schlamm, H. T.</author><author>Herbrecht, R.</author><author>Rottinghaus, S. T.</author><author>Bow, E. J.</author><author>Cornely, O. A.</author><author>Heinz, W. J.</author><author>Jagannatha, S.</author><author>Koh, L. P.</author><author>Kontoyiannis, D. P.</author><author>Lee, D. G.</author><author>Nucci, M.</author><author>Pappas, P. G.</author><author>Slavin, M. A.</author><author>Queiroz-Telles, F.</author><author>Selleslag, D.</author><author>Walsh, T. J.</author><author>Wingard, J. R.</author><author>Maertens, J. A.</author></authors></contributors><titles><title>Combination antifungal therapy for invasive aspergillosis: a randomized trial</title><secondary-title>Ann Intern Med</secondary-title><alt-title>Annals of internal medicine</alt-title></titles><periodical><full-title>Annals of Internal Medicine</full-title><abbr-1>Ann. Intern. Med.</abbr-1><abbr-2>Ann Intern Med</abbr-2></periodical><alt-periodical><full-title>Annals of Internal Medicine</full-title><abbr-1>Ann. Intern. Med.</abbr-1><abbr-2>Ann Intern Med</abbr-2></alt-periodical><pages>81-9</pages><volume>162</volume><number>2</number><dates><year>2015</year><pub-dates><date>Jan 20</date></pub-dates></dates><isbn>1539-3704 (Electronic)&#xD;0003-4819 (Linking)</isbn><accession-num>25599346</accession-num><urls><related-urls><url>;[364]. The trial enrolled 454 hematologic malignancy patients to evaluate hypothesized superiority in 6-week survival in combination therapy recipients. Mortality at 6 weeks was 19.3% for combination recipients and 27.5% for monotherapy recipients (p=0.087, 95% CI -19 to 1.5). Secondary mortality benefits favored combination therapy. In post-hoc analyses of the dominant subgroup of patients who were diagnosed as having ‘probable aspergillosis’ based on radiographic abnormalities and positive GM assays, the difference in mortality was most notable (15.7% combination vs. 27.3% monotherapy, p=0.037, 95% CI, -22.7 to -0.4). Global clinical responses at 6 weeks were lower in the combination group (33% vs 43%), which was attributed to more patients in the combination group being unevaluable for this secondary endpoint due to missing data. There were no toxicity differences. This study adds to prior pre-clinical and observational clinical studies that suggest potential benefits for combination therapy with voriconazole and an echinocandin PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Eb3dlbGw8L0F1dGhvcj48WWVhcj4yMDA1PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [200, 358, 365]. For this reason, the committee suggests consideration for an echinocandin with voriconazole for primary therapy in the setting of severe disease, especially in patients with hematologic malignancy and those with profound and persistent neutropenia. While caspofungin has been reported to have efficacy in several small non-comparative studies of drug administered for both primary and ‘salvage’ therapy, the committee does not support use of this agent as monotherapy based on lack of robustly powered comparative trials in which outcomes were not favorable compared to historical data PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5KYXJxdWU8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [192-194, 197, 366-368]. Duration of antifungal therapy for IPA is not well defined. We generally recommend that treatment of IPA be continued for a minimum of 6–12 weeks, depending on the severity and continuation of immunosuppression, as well as the extent of resolution of clinical disease. Therapeutic monitoring of IPA includes serial clinical evaluation of all symptoms and signs, as well as performance of radiographic imaging, usually with CT, at regular intervals. The frequency with which CT should be performed cannot be universally defined and should be individualized on the basis of the rapidity of evolution of pulmonary infiltrates and the acuity of illness in the individual patient. The volume of pulmonary infiltrates may increase for the first 7– 10 days of therapy, especially in the context of granulocyte recovery PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYWlsbG90PC9BdXRob3I+PFllYXI+MjAwMTwvWWVhcj48

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ADDIN EN.CITE.DATA [161]. The use of serial serum GM assays for therapeutic monitoring is promising but remains investigational. Progressive increases in Aspergillus antigen levels over time signify a poor prognosis. However, resolution of GM antigenemia to a normal level is not sufficient as a sole criterion for discontinuation of antifungal therapy. Long-term therapy of IA is facilitated by the availability of oral azole drugs in stable patients. For patients with successfully treated IA who will require subsequent immunosuppression, resumption of antifungal therapy can prevent recurrent infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3Jkb25uaWVyPC9BdXRob3I+PFllYXI+MjAxMDwvWWVh

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ADDIN EN.CITE.DATA [369, 370]. Surgical resection of Aspergillus-infected tissue may be useful in patients who have lesions that are contiguous with the great vessels or other critical organs, lesions causing recalcitrant hemoptysis from a single focus, and in lesions eroding into bone. This decision should be mindful of the probability of structural adhesion eliciting spillage of organism into the pleural space. As discussed in section II, increasing evidence suggests that attention should be placed on antifungal drug resistance, either that innate to the infecting Aspergillus species (such as A. terreus, A. flavus or ‘cryptic’ Aspergillus spp. such as A. lentulus) or that acquired by a typically susceptible species. Adjunctive measures and immunomodulation: When should withdrawal of immunosuppressive agents, or addition of CSFs or granulocyte transfusions be considered in the treatment of IA?Recommendations32.Reducing doses of, or eliminating altogether, immunosuppressive agents, when feasible, is advised as a component of anti-Aspergillus therapy (Strong Recommendation; Low Quality Evidence).33.CSFs may be considered in neutropenic patients with diagnosed or suspected IA (Weak Recommendation; Low Quality Evidence). There is insufficient evidence regarding the value of G-CSF versus GM-CSF in this setting.34.Granulocyte transfusions can be considered for neutropenic patients with IA that is refractory or are unlikely to respond to standard therapy, and for an anticipated duration of more than one week (Weak Recommendation; Low Quality Evidence). 35.Recombinant interferon- is recommended as prophylaxis in CGD patients (Strong Recommendation; High Quality Evidence). Its benefit as adjunctive therapy for IA is unknown.36.Surgery for aspergillosis should be considered for localized disease that is easily accessible to debridement (e.g., invasive fungal sinusitis or localized cutaneous disease) (Strong Recommendation; Low Quality Evidence). The benefit for IA in other settings such as in the treatment of endocarditis, osteomyelitis or focal central nervous system (CNS) disease appears rational. Other indications are less clear and require consideration of the patient’s immune status, co-morbidities, confirmation of a single focus, and the risks of surgery.Evidence summarySince immune reconstitution is an important factor in survival from IA, immunosuppressive agents should be tapered or removed, when possible. However, it is frequently not feasible to do so, for example, in patients with severe GVHD or in solid organ transplant recipients with allograft rejection. Clinical judgment is required in these cases. Colony-stimulating factors: Colony-stimulating factors administered prophylactically (prior to the onset of neutropenia) are commonly used to shorten the duration of neutropenia in patients receiving cytotoxic regimens. Granulocyte-colony stimulating factor (G-CSF) influences survival, proliferation, and differentiation of all cells in the neutrophil lineage and augments the function of mature neutrophils. Granulocyte macrophage-colony stimulating factor (GM-CSF) also stimulates neutrophil recovery and various neutrophil effector functions and is a potent activator of monocytes and macrophages. Pegfilgrastim, a pegylated formulation of G-CSF with a long half-life, is used to reduce the duration of neutropenia in patients with non-myeloid cancers.A meta-analysis of prophylactic G-CSF showed a reduction in the incidence of neutropenic fever and early deaths, including infection-related mortality PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdWRlcmVyPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48

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ADDIN EN.CITE.DATA [373, 374]. The value of adjunctive (as opposed to prophylactic) colony-stimulating factors for the treatment of major infections is unclear. Studies in vitro and in murine aspergillosis suggest that G-CSF and GM-CSF can enhance antifungal host defense PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CcnVtbWVyPC9BdXRob3I+PFllYXI+MjAwMTwvWWVhcj48

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ADDIN EN.CITE.DATA [375-378]. If not initiated in the prophylactic setting, use of colony-stimulating factors should be considered in neutropenic patients with diagnosed or suspected IA. Although colony-stimulating factors can augment phagocyte function in addition to cell numbers, there are insufficient data to recommend their use in patients who are not neutropenic.Granulocyte transfusions: The rationale for granulocyte transfusions is to increase the number of circulating neutrophils until neutrophil recovery occurs and is usually recommended as an adjunctive measure if granulocyte recovery is anticipated. Granulocyte transfusions have been used for decades as adjunctive treatment for severe infections in patients with neutropenia. The impetus to reevaluate granulocyte transfusions stems largely from improvements made in donor mobilization methods using therapy with G-CSF and corticosteroids PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZW5zaW5nZXI8L0F1dGhvcj48WWVhcj4xOTkzPC9ZZWFy

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ADDIN EN.CITE.DATA [380, 381]. A randomized trial evaluating the safety and effectiveness of granulocyte transfusions in patients with neutropenia and severe bacterial and fungal infections has recently been published (NCT00627393). Those who received an average dose per transfusion of >0.6 x 109 granulocytes/kg tended to have better outcomes than those receiving a lower dose PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QcmljZTwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [383]. Granulocyte transfusions can be considered for neutropenic patients with severe infections, including IA and other mould infections, which have failed or are unlikely to respond to standard therapy. Acute lung injury is the major risk of granulocyte transfusions. AmB may increase lung injury associated with granulocyte transfusions ADDIN EN.CITE <EndNote><Cite><Author>Wright</Author><Year>1981</Year><RecNum>27090</RecNum><DisplayText>[384]</DisplayText><record><rec-number>27090</rec-number><foreign-keys><key app="EN" db-id="a9a0zdws9s90ave9xrmxtf9h90pw2dxzptep">27090</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Wright, D. G.</author><author>Robichaud, K. J.</author><author>Pizzo, P. A.</author><author>Deisseroth, A. B.</author></authors></contributors><titles><title>Lethal pulmonary reactions associated with the combined use of amphotericin B and leukocyte transfusions</title><secondary-title>N Engl J Med</secondary-title><alt-title>The New England journal of medicine</alt-title></titles><periodical><full-title>N Engl J Med</full-title></periodical><pages>1185-9</pages><volume>304</volume><number>20</number><edition>1981/05/14</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Amphotericin B/administration &amp; dosage/*adverse effects</keyword><keyword>Anoxia/etiology</keyword><keyword>Blood Transfusion/*adverse effects</keyword><keyword>Child</keyword><keyword>Dyspnea/etiology</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>*Leukocyte Transfusion</keyword><keyword>Lung Diseases/*etiology</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Neutropenia/therapy</keyword><keyword>Sepsis/therapy</keyword></keywords><dates><year>1981</year><pub-dates><date>May 14</date></pub-dates></dates><isbn>0028-4793 (Print)&#xD;0028-4793 (Linking)</isbn><accession-num>7219459</accession-num><urls><related-urls><url>;[384]; therefore, separating AmB and granulocyte infusions by several hours is advised. Alloimmunization leading to graft failure after allogeneic HSCT is another potential risk of granulocyte transfusions. In allogeneic transplants in which the donor and recipient are seronegative for CMV, use of CMV-seronegative granulocyte donors is recommended. Recombinant Interferon-: IFN- augments the antifungal activity of macrophages and neutrophils ex vivo against a variety of fungal pathogens, including Aspergillus species. A high proportion of patients with chronic pulmonary aspergillosis are poor producers of IFN- ADDIN EN.CITE <EndNote><Cite><Author>Smith</Author><Year>2014</Year><RecNum>27092</RecNum><DisplayText>[385]</DisplayText><record><rec-number>27092</rec-number><foreign-keys><key app="EN" db-id="a9a0zdws9s90ave9xrmxtf9h90pw2dxzptep">27092</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Smith, N. L.</author><author>Denning, D. W.</author></authors></contributors><auth-address>Manchester Fungal Infection Group, Faculty of Medical and Human Science, The University of Manchester, UK; Faculty of Medical and Human Science, The University of Manchester; Manchester Academic Health Science Centre; University Hospital South Manchester NHS Foundation Trust; NIHR South Manchester Respiratory and Allergy Clinical Research Facility, Manchester, UK.</auth-address><titles><title>Clinical implications of interferon gamma genetic and epigenetic variants</title><secondary-title>Immunology</secondary-title><alt-title>Immunology</alt-title></titles><periodical><full-title>Immunology</full-title></periodical><alt-periodical><full-title>Immunology</full-title></alt-periodical><edition>2014/07/24</edition><dates><year>2014</year><pub-dates><date>Jul 22</date></pub-dates></dates><isbn>1365-2567 (Electronic)&#xD;0019-2805 (Linking)</isbn><accession-num>25052001</accession-num><urls><related-urls><url>;[385]. In addition, a high ratio of ex vivo T cell production of IFN-/IL-10 is associated with improved responses to antifungal therapy in patients with IA ADDIN EN.CITE <EndNote><Cite><Author>Hebart</Author><Year>2002</Year><RecNum>4890</RecNum><DisplayText>[386]</DisplayText><record><rec-number>4890</rec-number><foreign-keys><key app="EN" db-id="a9a0zdws9s90ave9xrmxtf9h90pw2dxzptep">4890</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hebart, H.</author><author>Bollinger, C.</author><author>Fisch, P.</author><author>Sarfati, J.</author><author>Meisner, C.</author><author>Baur, M.</author><author>Loeffler, J.</author><author>Monod, M.</author><author>Latge, J. P.</author><author>Einsele, H.</author></authors></contributors><titles><title>Analysis of T-cell responses to Aspergillus fumigatus antigens in healthy individuals and patients with hematologic malignancies</title><secondary-title>Blood</secondary-title></titles><periodical><full-title>Blood</full-title></periodical><pages>4521-4528.</pages><volume>100</volume><number>13</number><dates><year>2002</year></dates><label>0</label><urls><related-urls><url>;[386]. rIFN- is licensed as a prophylactic agent for patients with chronic granulomatous disease on the basis of a randomized trial in which rIFN- reduced the number and severity of infections (mostly bacterial) in patients with chronic granulomatous disease by ～70% ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1"><Year>1991</Year><RecNum>5341</RecNum><DisplayText>[387]</DisplayText><record><rec-number>5341</rec-number><foreign-keys><key app="EN" db-id="a9a0zdws9s90ave9xrmxtf9h90pw2dxzptep">5341</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease. The International Chronic Granulomatous Disease Cooperative Study Group.</title><secondary-title>N Engl J Med</secondary-title></titles><periodical><full-title>N Engl J Med</full-title></periodical><pages>509-16</pages><volume>324</volume><number>8</number><keywords><keyword>Adolescence</keyword><keyword>Child</keyword><keyword>Double-Blind Method</keyword><keyword>Female</keyword><keyword>Granulomatous Disease, Chronic/*complications/genetics/immunology</keyword><keyword>Human</keyword><keyword>Infection/*prevention &amp; control</keyword><keyword>*Infection Control</keyword><keyword>Injections, Subcutaneous</keyword><keyword>Interferon-gamma, Recombinant/administration &amp; dosage/adverse effects/*therapeutic use</keyword><keyword>Male</keyword><keyword>Phagocytes/metabolism</keyword><keyword>Phagocytosis</keyword><keyword>Recurrence</keyword><keyword>Staphylococcus/immunology</keyword><keyword>Superoxides/metabolism</keyword><keyword>Support, Non-U.S. Gov&apos;t</keyword><keyword>Support, U.S. Gov&apos;t, P.H.S.</keyword><keyword>Time Factors</keyword></keywords><dates><year>1991</year></dates><label>91125407</label><urls></urls></record></Cite></EndNote>[387]. 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ADDIN EN.CITE.DATA [369, 390-393]. An acceptable approach in patients with pre-transplant aspergillosis is close CT monitoring without surgical resection in the absence of additional complications, such as uncontrolled bleeding or chest wall extension. Decisions concerning surgical therapy should be individualized to account for a number of variables, including the degree of resection (e.g., wedge resection vs. pneumonectomy), potential impact of delays in chemotherapy, comorbidities, performance status, the goal of antineoplastic therapy (e.g., curative vs. palliative), and unilateral versus bilateral lesions.When is it safe to proceed with chemotherapy or transplantation in a patient with IA?Recommendations37.IA is not an absolute contraindication to additional chemotherapy or HSCT (Strong recommendation; Moderate Quality Evidence).38.Decisions about when to proceed with additional chemotherapy or HSCT following the diagnosis of aspergillosis should involve both Infectious Diseases specialists and Hematologists/Oncologists. These decisions must consider the risk of progressive aspergillosis during periods of subsequent anti-neoplastic treatment versus the risk of death from the underlying malignancy if this treatment is delayed (Strong Recommendation; Low Quality Evidence).Evidence summaryPatients with malignancy and IA frequently require additional anti-neoplastic therapy and/or HSCT. The major concern is that aspergillosis will progress during subsequent periods of immunosuppression. Several studies have shown that IA is not a contraindication for additional treatment, including HSCT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PZmZuZXI8L0F1dGhvcj48WWVhcj4xOTk4PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [369, 390-393]. It is important to administer mould-active antifungal treatment during subsequent periods of immunosuppression (referred to as secondary prophylaxis) to avoid recurrence or progression. In a multicenter retrospective survey of patients with pre-transplant aspergillosis, 27 of 129 patients developed progressive fungal disease following allogeneic HSCT. The variables that increased the 2-year cumulative incidence of aspergillosis progression were longer duration of neutropenia after transplantation, refractory malignancy, and less than 6 weeks from start of antifungal therapy and HSCT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJ0aW5vPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [391]. In a prospective, multicenter trial of voriconazole as secondary prophylaxis in patients with pre-transplant invasive fungal infections (the majority were aspergillosis), the 1-year cumulative incidence of invasive fungal disease was 7% following allogeneic HSCT PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3Jkb25uaWVyPC9BdXRob3I+PFllYXI+MjAxMDwvWWVh

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ADDIN EN.CITE.DATA [369].Decisions about when to proceed with additional chemotherapy or HSCT following the diagnosis of aspergillosis must consider the risks of progressive aspergillosis and the risks of delaying treatment of the underlying malignancy. These decisions require expertise from Infectious Diseases specialists and oncologists. From the infectious disease standpoint, a period of several weeks of antifungal treatment and clear evidence of response to therapy is ideal before administering additional chemotherapy or HSCT. However, there are situations when this approach is not feasible, for example, in patients with refractory or relapsed acute leukemia who require urgent re-induction therapy.What approaches are needed for refractory or progressive aspergillosis (salvage therapy)?Recommendations39.We recommend an individualized approach that takes into consideration the rapidity, severity, extent of infection, patient co-morbidities, and to exclude the emergence of a new pathogen (Strong Recommendation; Low Quality Evidence). The general strategies for salvage therapy typically include, (i) changing the class of antifungal; (ii) tapering or reversal of underlying immunosuppression when feasible, and (iii) surgical resection of necrotic lesions in selected cases.40. In the context of salvage therapy, an additional antifungal agent may be added to current therapy, or combination antifungal drugs from different classes other than those in the initial regimen may be used (Weak Recommendation; Moderate Quality Evidence).41.In patients currently receiving an antifungal and exhibiting an adverse event attributable to this agent, we recommend changing to an alternative class of antifungal, or the use of an alternative agent with a non-overlapping side-effect profile (Strong Recommendation; Low Quality Evidence).42.For salvage therapy, agents include lipid formulations of AmB, micafungin, caspofungin, posaconazole or itraconazole. The use of a triazole as salvage therapy should take into account prior antifungal therapy, host factors, pharmacokinetic considerations, and possible antifungal resistance (Strong Recommendation; Moderate Quality Evidence).Evidence summaryMany issues confound the interpretation of current published evidence for salvage therapy for IA including publication bias, inadequate statistical power, and heterogeneity of studies. In salvage therapy studies, differentiating Aspergillus-attributable mortality versus the impact of underlying disease or co-infections is not possible PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbG15cm91ZGlzPC9BdXRob3I+PFllYXI+MjAwNjwvWWVh

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ADDIN EN.CITE.DATA [161]. Salvage therapy trials that enroll patients after only 7 days of antifungal therapy may not adequately account for this phenomenon. Antifungal therapy initiated at the time of neutrophil recovery is also biased by the salutatory effects of immune recovery.In addition, there is confusion in some studies between sequential versus true salvage therapy as the action of the failing drug may interact with the action of the salvage drug. The first drug may inflict damage to Aspergillus that enhances the action of the second drug, or there may be neutral or possibly even antagonistic effect. Another issue relates to antifungal agents with prolonged half-lives such as AmB formulations ADDIN EN.CITE <EndNote><Cite><Author>Kontoyiannis</Author><Year>2004</Year><RecNum>190</RecNum><DisplayText>[396]</DisplayText><record><rec-number>190</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413393544">190</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kontoyiannis, D. P.</author><author>Lewis, R. E.</author></authors></contributors><auth-address>Department of Infectious Diseases, Infection Control and Employee Health, The University of Texas M. D. Anderson Cancer Center, and College of Pharmacy, University of Houston, 77030, USA. dkontoyi@</auth-address><titles><title>Toward more effective antifungal therapy: the prospects of combination therapy</title><secondary-title>Br J Haematol</secondary-title><alt-title>British journal of haematology</alt-title></titles><periodical><full-title>British Journal of Haematology</full-title><abbr-1>Br. J. Haematol.</abbr-1><abbr-2>Br J Haematol</abbr-2></periodical><alt-periodical><full-title>British Journal of Haematology</full-title><abbr-1>Br. J. Haematol.</abbr-1><abbr-2>Br J Haematol</abbr-2></alt-periodical><pages>165-75</pages><volume>126</volume><number>2</number><keywords><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Aspergillosis/drug therapy</keyword><keyword>Aspergillus/drug effects</keyword><keyword>Candida/drug effects</keyword><keyword>Candidiasis/drug therapy</keyword><keyword>Cryptococcus/drug effects</keyword><keyword>Drug Combinations</keyword><keyword>Drug Therapy, Combination</keyword><keyword>Humans</keyword><keyword>*Immunocompromised Host</keyword></keywords><dates><year>2004</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>0007-1048 (Print)&#xD;0007-1048 (Linking)</isbn><accession-num>15238137</accession-num><urls><related-urls><url>;[396]. Thus, in patients receiving AmB-based initial therapy, the combined action of both AMB and the “salvage” antifungal agent will be present for several days to a week after cessation of AMB therapy. Finally, most salvage studies do not provide a robust explanation for the lack of response (e.g., failure due to drug resistance or co-infection, disadvantageous PK/PD, intolerance to a study drug, or lack of recovery from immunosuppression). The principle antifungal agents considered for salvage therapy include lipid formulations of AmB, posaconazole, itraconazole, and the echinocandins, caspofungin and micafungin, which have both been evaluated in salvage settings PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZzwvQXV0aG9yPjxZZWFyPjE5OTU8L1llYXI+PFJlY051

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ADDIN EN.CITE.DATA [257, 358, 397-400]. Voriconazole can also be considered as a salvage agent if not used in primary therapy as could presumably isavuconazole, although isavuconazole has limited evaluation in the salvage setting. In patients who fail initial triazole therapy, a change in class to an AmB formulation (usually liposomal AmB) with or without an echinocandin, should be considered. Azole-specific pharmacokinetic problems must also be considered, including therapeutic drug monitoring. Most of the prospective studies of second-line therapy have been conducted by replacing the compound to which the patient is intolerant or against which the infection is progressing. Whether both drugs should be administered simultaneously has seldom been prospectively studied PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZW5uaW5nPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [196]. The addition of a second antifungal agent to a first agent that is failing is usually practiced out of understandable lack of therapeutic options. Other drug combinations have not been extensively studied ADDIN EN.CITE <EndNote><Cite><Author>Steinbach</Author><Year>2011</Year><RecNum>227</RecNum><DisplayText>[299]</DisplayText><record><rec-number>227</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413844300">227</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Steinbach, W. J.</author><author>Juvvadi, P. R.</author><author>Fortwendel, J. R.</author><author>Rogg, L. E.</author></authors></contributors><auth-address>Department of Pediatrics, Division of Pediatric Infectious Diseases, Duke University, Durham, NC 27710, USA. stein022@mc.duke.edu</auth-address><titles><title>Newer combination antifungal therapies for invasive aspergillosis</title><secondary-title>Med Mycol</secondary-title><alt-title>Medical mycology</alt-title></titles><periodical><full-title>Medical Mycology</full-title><abbr-1>Med. Mycol.</abbr-1><abbr-2>Med Mycol</abbr-2></periodical><alt-periodical><full-title>Medical Mycology</full-title><abbr-1>Med. Mycol.</abbr-1><abbr-2>Med Mycol</abbr-2></alt-periodical><pages>S77-81</pages><volume>49 Suppl 1</volume><keywords><keyword>Animals</keyword><keyword>Antifungal Agents/pharmacology/*therapeutic use</keyword><keyword>Aspergillosis/*drug therapy/microbiology</keyword><keyword>Aspergillus/*drug effects/pathogenicity</keyword><keyword>Calcineurin/drug effects/metabolism</keyword><keyword>Disease Models, Animal</keyword><keyword>Drug Therapy, Combination</keyword><keyword>HSP90 Heat-Shock Proteins/drug effects/physiology</keyword><keyword>Humans</keyword></keywords><dates><year>2011</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1460-2709 (Electronic)&#xD;1369-3786 (Linking)</isbn><accession-num>20608784</accession-num><urls><related-urls><url>;[299]. Additional questions of optimal drug combinations, optimal drug dosing, pharmacokinetic interactions, potential toxic interactions, and cost-benefit ratios of primary combination antifungal therapy require further investigation.The need for surgical resection should be evaluated in cases of pulmonary lesions contiguous with the heart or great vessels, invasion of the chest wall, massive hemoptysis and other special circumstances. Restoration of or improvement in impaired host defenses is critical for improved outcome of IA. Correction of co-morbidities using various adjunctive strategies (e.g., correction of hyperglycemia, recovery from neutropenia, or reduction of immunosuppressive medication dosages) is expected to improve outcomes in progressive IA but may also be associated with IRIS.How can biomarkers be used to assess patient response to therapy?Recommendations43.Serial monitoring of serum GM can be used in the appropriate patient subpopulations (hematologic malignancy, HSCT) who have an elevated GM at baseline to monitor disease progression, therapeutic response, and predict outcome (Strong Recommendation; Moderate Quality Evidence). 44.(1→3)-β-D-glucan has not been extensively studied in IA to predict outcome (Weak Recommendation; Low Quality Evidence).Evidence summaryMultiple studies have evaluated serial serum GM for both therapeutic monitoring as well as predicting prognosis and found excellent correlations between GMI and outcomes. A review of 27 published studies, including both adult and pediatric allogeneic or autologous HSCT recipients, found an excellent correlation between GMI and survival, including autopsy findings ADDIN EN.CITE <EndNote><Cite><Author>Miceli</Author><Year>2008</Year><RecNum>1224</RecNum><DisplayText>[401]</DisplayText><record><rec-number>1224</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1224</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Miceli, M. H.</author><author>Grazziutti, M. L.</author><author>Woods, G.</author><author>Zhao, W.</author><author>Kocoglu, M. H.</author><author>Barlogie, B.</author><author>Anaissie, E.</author></authors></contributors><auth-address>Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR 72205, USA.</auth-address><titles><title>Strong correlation between serum aspergillus galactomannan index and outcome of aspergillosis in patients with hematological cancer: clinical and research implications</title><secondary-title>Clinical Infectious Diseases</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin Infect Dis</abbr-1></periodical><pages>1412-22</pages><volume>46</volume><number>9</number><edition>2008/04/19</edition><keywords><keyword>Aspergillosis/blood/complications/ pathology</keyword><keyword>Aspergillus/drug effects/ metabolism</keyword><keyword>Hematologic Neoplasms/ complications</keyword><keyword>Humans</keyword><keyword>Mannans/ blood</keyword><keyword>Meta-Analysis as Topic</keyword><keyword>Prognosis</keyword><keyword>Survival Analysis</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2008</year><pub-dates><date>May 1</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>18419445</accession-num><urls></urls><electronic-resource-num>10.1086/528714</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[401]. 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ADDIN EN.CITE.DATA [404]. GMI-based assessment can also predict outcome sooner ADDIN EN.CITE <EndNote><Cite><Author>Nouer</Author><Year>2011</Year><RecNum>1225</RecNum><DisplayText>[405]</DisplayText><record><rec-number>1225</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1225</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nouer, S. A.</author><author>Nucci, M.</author><author>Kumar, N. S.</author><author>Grazziutti, M.</author><author>Barlogie, B.</author><author>Anaissie, E.</author></authors></contributors><auth-address>Department of Preventive Medicine and Myeloma Institute forResearch and Therapy, University of Arkansas for Medical Sciences, Little Rock, AR, USA.</auth-address><titles><title>Earlier response assessment in invasive aspergillosis based on the kinetics of serum Aspergillus galactomannan: proposal for a new definition</title><secondary-title>Clinical Infectious Diseases</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin Infect Dis</abbr-1></periodical><pages>671-6</pages><volume>53</volume><number>7</number><edition>2011/08/19</edition><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>Drug Monitoring/ methods</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Invasive Pulmonary Aspergillosis/ diagnosis/ drug therapy</keyword><keyword>Male</keyword><keyword>Mannans/ blood</keyword><keyword>Middle Aged</keyword><keyword>Serum/ chemistry</keyword><keyword>Time Factors</keyword></keywords><dates><year>2011</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>21846834</accession-num><urls></urls><custom2>3166349</custom2><electronic-resource-num>10.1093/cid/cir441</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>[405]. Several studies have compared the initial GMI and subsequent rate of daily decay of GM, defined as the change from the initial GMI divided by the number of days since that initial value. Both initial GMI and rate of decrease of GM in response to therapy at one week after initiation of therapy have been predictive of mortality PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYWRyaWNoPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48

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ADDIN EN.CITE.DATA [407]. GMI is also predictive of outcome in non-neutropenic patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SdXNzbzwvQXV0aG9yPjxZZWFyPjIwMTQ8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [408-410]. A retrospective evaluation of the global aspergillosis clinical trial comparing voriconazole to AmB deoxycholate followed by other licensed therapy ADDIN EN.CITE <EndNote><Cite><Author>Herbrecht</Author><Year>2002</Year><RecNum>619</RecNum><DisplayText>[411]</DisplayText><record><rec-number>619</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">619</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Herbrecht, R</author><author>Denning, D W</author><author>Patterson, T F</author><author>Bennett, J E</author><author>Greene, R E</author><author>Oestmann, J W</author><author>Kern, W V</author><author>Marr, K A</author><author>Ribaud, P</author><author>Lortholary, O</author><author>Sylvester, R</author><author>Rubin, R H</author><author>Wingard, J R</author><author>Stark, P</author><author>Durand, C</author><author>Caillot, D</author><author>Thiel, E</author><author>Chandrasekar, P H</author><author>Hodges, M R</author><author>Schlamm, H T</author><author>Troke, P F</author><author>de Pauw, B</author></authors></contributors><titles><title>Voriconazole versus amphotericin B for primary therapy of invasive aspergillosis</title><secondary-title>New England Journal of Medicine</secondary-title></titles><periodical><full-title>New England Journal of Medicine</full-title><abbr-1>N Engl J Med</abbr-1></periodical><pages>408-415</pages><volume>347</volume><dates><year>2002</year></dates><urls></urls></record></Cite></EndNote>[411], found that GMI at week one was significantly lower than baseline GM in the eventual twelve-week responders compared to non-responders. A GMI reduction of > 35% between baseline and week one predicted a probability of a satisfactory clinical response, while during antifungal treatment every 0.1 unit increase in GMI between baseline and week two increased the likelihood of a poor response by 21.6% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFpPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [404]. In a single center retrospective study, initial (1→3)-β-D-glucan value and early kinetics of (1→3)-β-D-glucan were not predictive of 6- or 12-week clinical outcome or mortality in IA ADDIN EN.CITE <EndNote><Cite><Author>Koo</Author><Year>2012</Year><RecNum>1195</RecNum><DisplayText>[415]</DisplayText><record><rec-number>1195</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1195</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Koo, S</author><author>Baden, L R</author><author>Marty, F M</author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Post-diagnostic kinetics of the (1 → 3)-</style><style face="normal" font="default" charset="161" size="100%">β-D-glucan assay in invasive aspergillosis, invasive candidiasis and Pneumocystis jirovecii pneumonia</style></title><secondary-title>Clinical Microbiology and Infection</secondary-title></titles><periodical><full-title>Clinical Microbiology and Infection</full-title><abbr-1>Clin Microbiol Infect</abbr-1></periodical><pages>e122-7</pages><volume>18</volume><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>[415]. What are the recommended treatments for pediatric patients with aspergillosis?Recommendation45.Treatment of aspergillosis in children uses the same recommended therapies as in adult patients, however the dosing is different and for some antifungals is unknown (Strong Recommendation; High Quality Evidence).Evidence summaryTreatment in children follows the recommendations used for adults, yet antifungal dosing in children is often significantly different. Under-dosing in children is a common etiology of insufficient drug levels and possibly clinical failures. Voriconazole, while only FDA-approved for children 12 years of age and older, is the mainstay of pediatric aspergillosis treatment in all ages due to substantial pharmacokinetic data and experience. Fundamental pharmacokinetics of voriconazole are different in children (linear) than in adults (non-linear) ADDIN EN.CITE <EndNote><Cite><Author>Walsh</Author><Year>2004</Year><RecNum>936</RecNum><DisplayText>[292]</DisplayText><record><rec-number>936</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">936</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Walsh, T J</author><author>Karlsson, M O</author><author>Driscoll, T</author><author>Arguedas, A G</author><author>Adamson, P</author><author>Saez-Llorens, X</author><author>Vora, A J</author><author>Arrieta, A C</author><author>Blumer, J</author><author>Lutsar, I</author><author>Milligan, P</author><author>Wood, N</author></authors></contributors><titles><title>Pharmacokinetics and safety of intravenous voriconazole in children after single- or multiple-dose administration</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>2166-2172</pages><volume>48</volume><dates><year>2004</year></dates><urls></urls></record></Cite></EndNote>[292]. While voriconazole in adults is loaded at 6 mg/kg/dose twice daily, followed by 4 mg/kg/dose twice daily, the preferred pediatric dosing is substantially higher. Population pharmacokinetic analyses of voriconazole reveal that children should be given an intravenous 9 mg/kg loading dose twice daily to be comparable to 6 mg/kg/dose in adults ADDIN EN.CITE <EndNote><Cite><Author>Friberg</Author><Year>2012</Year><RecNum>1062</RecNum><DisplayText>[416]</DisplayText><record><rec-number>1062</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1062</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Friberg, L E</author><author>Ravva, P</author><author>Karlsson, M O</author><author>Liu, P</author></authors></contributors><titles><title>Integrated population pharmacokinetic analysis of voriconazole in children, adolescents, and adults</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>3032-42</pages><volume>56</volume><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>[416]. Maintenance intravenous dosing in children at 8 mg/kg/dose was comparable to 4 mg/kg/dose in adults, and the oral dosing of 9 mg/kg/dose was similar to adults receiving 200 mg oral voriconazole twice daily. The majority of adolescents can be dosed as adults, but in younger adolescents (ages 12-14) body weight is more important than age in predicting voriconazole pharmacokinetics. Therefore, younger adolescents should be dosed as children if their weight is <50 kg and as adults if their weight is ≥50 kg ADDIN EN.CITE <EndNote><Cite><Author>Friberg</Author><Year>2012</Year><RecNum>1062</RecNum><DisplayText>[416]</DisplayText><record><rec-number>1062</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1062</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Friberg, L E</author><author>Ravva, P</author><author>Karlsson, M O</author><author>Liu, P</author></authors></contributors><titles><title>Integrated population pharmacokinetic analysis of voriconazole in children, adolescents, and adults</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>3032-42</pages><volume>56</volume><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>[416]. Additionally, the oral bioavailability of voriconazole, felt to be >95% in adults, is lower in children at approximately 50-65% ADDIN EN.CITE <EndNote><Cite><Author>Walsh</Author><Year>2010</Year><RecNum>990</RecNum><DisplayText>[417, 418]</DisplayText><record><rec-number>990</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">990</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Walsh, T J</author><author>Driscoll, T</author><author>Milligan, P A</author><author>Wood, N D</author><author>Schlamm, H</author><author>Groll, A H</author><author>Jafri, H</author><author>Arrieta, A C</author><author>Klein, N J</author><author>Lutsar, I</author></authors></contributors><titles><title>Pharmacokinetics, safety, and tolerability of voriconazole in immunocompromised children</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>4116-4123</pages><volume>54</volume><dates><year>2010</year></dates><urls></urls></record></Cite><Cite><Author>Karlsson</Author><Year>2009</Year><RecNum>960</RecNum><record><rec-number>960</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">960</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Karlsson, M O</author><author>Lutsar, I</author><author>Milligan, P A</author></authors></contributors><titles><title>Population pharmacokinetic analysis of voriconazole plasma concentration data from pediatric studies</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>935-944</pages><volume>53</volume><dates><year>2009</year></dates><urls></urls></record></Cite></EndNote>[417, 418]. As in adult patients, there are still suggestions of the need for higher voriconazole doses ADDIN EN.CITE <EndNote><Cite><Author>Pascual</Author><Year>2012</Year><RecNum>1063</RecNum><DisplayText>[293]</DisplayText><record><rec-number>1063</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">1063</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pascual, A</author><author>Csajka, C</author><author>Buclin, T</author><author>Bolay, S</author><author>Bille, J</author><author>Calandra, T</author><author>Marchetti, O</author></authors></contributors><titles><title>Challenging recommended oral and intravenous voriconazole doses for improved efficacy and safety: population pharmacokinetics-based analysis of adult patients with invasive fungal infections</title><secondary-title>Clinical Infectious Diseases</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin Infect Dis</abbr-1></periodical><pages>381-90</pages><volume>55</volume><dates><year>2012</year></dates><urls></urls></record></Cite></EndNote>[293] and drug monitoring is paramount. Posaconazole is FDA-approved for children 13 years and older for both the oral suspension and tablet, and for 18 years and older for the intravenous formulation. As such, pediatric dosing has not yet been fully defined. Caspofungin is FDA-approved for children 3 months and older and dosing is based on body surface area, with a loading dose of 70 mg/m2, followed by daily maintenance dosing of 50 mg/m2, not to exceed 70 mg ADDIN EN.CITE <EndNote><Cite><Author>Walsh</Author><Year>2005</Year><RecNum>635</RecNum><DisplayText>[419]</DisplayText><record><rec-number>635</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">635</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Walsh, T J</author><author>Adamson, P C</author><author>Seibel, N L</author><author>Flynn, P M</author><author>Neely, M N</author><author>Schwartz, C</author><author>Shad, A</author><author>Kaplan, S L</author><author>Roden, M M</author><author>Stone, J A</author><author>Miller, A</author><author>Bradshaw, S K</author><author>Li, S X</author><author>Sable, C A</author><author>Kartsonis, N A</author></authors></contributors><titles><title>Pharmacokinetics, safety, and tolerability of caspofungin in children and adolescents</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>4536-4545</pages><volume>49</volume><dates><year>2005</year></dates><urls></urls></record></Cite></EndNote>[419]. Micafungin is FDA-approved for children 4 months and older and clearance increases in younger age groups. Doses in children are 2-3 mg/kg/day, with higher doses for younger children and patients >40 kg use the adult dose (100 mg) ADDIN EN.CITE <EndNote><Cite><Author>Seibel</Author><Year>2005</Year><RecNum>878</RecNum><DisplayText>[420]</DisplayText><record><rec-number>878</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">878</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Seibel, N L</author><author>Schwartz, C</author><author>Arrieta, A</author><author>Flynn, P</author><author>Shad, A</author><author>Albano, E</author><author>Keirns, J</author><author>Lau, W M</author><author>Facklam, D P</author><author>Buell, D N</author><author>Walsh, T J</author></authors></contributors><titles><title>Safety, tolerability, and pharmacokinetics of micafungin (FK463) in febrile neutropenic pediatric patients</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>3317-3324</pages><volume>49</volume><dates><year>2005</year><pub-dates><date>17-20 September, 2000</date></pub-dates></dates><urls></urls></record></Cite></EndNote>[420]. Anidulafungin is not FDA-approved for children and a single pharmacokinetic study in children suggested a loading dose of 1.5-3 mg/kg and maintenance dose of 0.75-1.5 mg/kg ADDIN EN.CITE <EndNote><Cite><Author>Benjamin</Author><Year>2006</Year><RecNum>875</RecNum><DisplayText>[421]</DisplayText><record><rec-number>875</rec-number><foreign-keys><key app="EN" db-id="fpwed2pr9zavtjetdtj5dtdrpw05ffsfwrex">875</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Benjamin, D K Jr.</author><author>Driscoll, T</author><author>Seibel, N L</author><author>Gonzalez, C E</author><author>Roden, M M</author><author>Kilaru, R</author><author>Dowell, J A</author><author>Schranz, J</author><author>Walsh, T J</author></authors></contributors><titles><title>Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections</title><secondary-title>Antimicrobial Agents and Chemotherapy</secondary-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob Agents Chemother</abbr-1></periodical><pages>632-638</pages><volume>50</volume><dates><year>2006</year></dates><urls></urls></record></Cite></EndNote>[421]. Dosing of lipid formulations of AmB does not differ in children.What are treatment options for aspergillosis of the airways in transplant and nontransplant recipients and how does it differ from IPA?Recommendations46.Saprophytic forms of tracheobronchial aspergillosis (TBA) do not require antifungal treatment except for symptomatic or immunosuppressed patients. Treatment includes bronchoscopic removal of mucoid impaction. Mould-active triazole agents are recommended for immunocompromised patients in whom the possibility of invasive disease cannot be eliminated. (Strong Recommendation; Moderate Quality Evidence) 47.Bronchocentric granulomatosis is treated in the same fashion as allergic bronchopulmonary aspergillosis (ABPA). (Strong Recommendation; Low Quality Evidence). 48.Invasive forms of TBA are treated with a mould-active triazole or intravenous lipid formulations of AmB (Strong Recommendation; Moderate Quality Evidence). We also recommend minimization or reversal of underlying immunosuppression when feasible, and bronchoscopic debridement of airway lesions in selected cases (Strong Recommendation; Low Quality Evidence).49.In lung transplant recipients, we recommend treatment with a systemic anti-mould antifungal for TBA, including saprophytic forms. We also recommend adjunctive inhaled AmB in the setting of TBA associated with anastomotic endobronchial ischemia or ischemic reperfusion injury due to airway ischemia associated with lung transplantation (Strong Recommendation; Moderate Quality Evidence). Duration of antifungal therapy is at least 3 months or until TBA is completely resolved, whichever is longer.Evidence summaryAirway aspergillosis (or tracheobronchial aspergillosis [TBA]) is similar to pulmonary aspergillosis in that it can occur in saprophytic, allergic (ABPA), or invasive forms. There is also an emerging entity of Aspergillus bronchitis among CF patients, and others with bronchiectasis. The diagnosis of TBA is suggested by bronchoscopic findings and confirmed by culture and histopathology. Due to the limited number of studies, optimal evidence-based therapy is not clear, and recommendations are extrapolated from experience in treating invasive lung parenchymal aspergillosis and TBA case series. Saprophytic forms of TBA include obstructing bronchial aspergillosis, endobronchial aspergillosis and mucoid impaction. Obstructing bronchial aspergillosis is characterized by thick mucous plugs with minimal or no airway inflammation PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LcmVua2U8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [422, 423]. Patients commonly present with the subacute onset of cough, dyspnea, chest pain, hemoptysis and expectoration of fungal casts. Management typically consists of bronchoscopic clearance usually followed by oral antifungal therapy. Endobronchial aspergillosis is generally found among patients with lesions such as broncholiths, cancer, or granulation tissue or suture material at the anastomotic site after lung resection. It is manifested as endobronchial lesions or mucous plugs in or around the bronchial stumps or sutures. In general, these saprophytic forms do not require systemic antifungal therapy unless patients are immunocompromised and locally invasive disease cannot be ruled out ADDIN EN.CITE <EndNote><Cite><Author>Soubani</Author><Year>2002</Year><RecNum>26</RecNum><DisplayText>[423]</DisplayText><record><rec-number>26</rec-number><foreign-keys><key app="EN" db-id="ew9apwdzc05eeeeespxv52fn9tz0xzx00zrt">26</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Soubani, A. O.</author><author>Chandrasekar, P. H.</author></authors></contributors><auth-address>Division of Pulmonary, Critical Care, and Sleep Medicine, Wayne State University School of Medicine, Detroit, MI 48201, USA. asoubani@intmed.wayne.edu</auth-address><titles><title>The clinical spectrum of pulmonary aspergillosis</title><secondary-title>Chest</secondary-title><alt-title>Chest</alt-title></titles><periodical><full-title>Chest</full-title><abbr-1>Chest</abbr-1></periodical><alt-periodical><full-title>Chest</full-title><abbr-1>Chest</abbr-1></alt-periodical><pages>1988-99</pages><volume>121</volume><number>6</number><keywords><keyword>Aspergillosis/complications/*diagnosis/therapy</keyword><keyword>Aspergillosis, Allergic Bronchopulmonary/complications/*diagnosis/therapy</keyword><keyword>Humans</keyword><keyword>Lung Diseases, Fungal/complications/*diagnosis/therapy</keyword></keywords><dates><year>2002</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0012-3692 (Print)&#xD;0012-3692 (Linking)</isbn><accession-num>12065367</accession-num><urls><related-urls><url>;[423]. In symptomatic patients, local debridement or suture removal can be performed. There is no consistent evidence that systemic, inhaled, or local injection with an antifungal agent is effective in treating these forms of disease. Mucoid impaction is a clinical-radiographic syndrome characterized by inspissated mucus filling of the bronchi PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LcmVua2U8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [422, 423]. Finger-in-glove sign, referring to branching tubular opacities that extend peripherally, is the classic chest radiograph finding. Patients can be asymptomatic, or present with cough and expectoration of mucous plugs. Mucoid impaction is commonly associated with inflammatory conditions of the airways (such as bronchiectasis and ABPA), benign processes (such as broncholithiasis, foreign body aspiration, endobronchial lipoma, hamartoma or papilloma) and malignant processes (such as carcinoid tumor or lung malignancies) causing obstruction of large airways. Mucous plugging that may appear hyperattenuated on computed tomography seems to be a particularly distinctive feature of ABPA, probably more common in India, with a high propensity for early relapse and corticosteroid dependence. Mucoid impaction associated with bronchiectasis is treated with maneuvers to promote airway clearance (chest physiotherapy, positive expiratory pressure and vibration devices, mucolytics, nebulized hypertonic saline) and treatment of airway infection (antimicrobial agents). Mucoid impaction associated with features of asthma and hypersensitization to Aspergillus is treated as for ABPA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LcmVua2U8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [422]. Bronchocentric granulomatosis is a form of ABPA that is characterized histopathologically by necrotizing granulomas with airway obstruction that destroy the bronchioles but there is no tissue invasion by Aspergillus. Bronchoscopic findings include impaction of airway lumen by mucin and cellular debris. Treatment is similar to that of ABPA (see recommendations 92--94 below) ADDIN EN.CITE <EndNote><Cite><Author>Denning</Author><Year>1990</Year><RecNum>31</RecNum><DisplayText>[424]</DisplayText><record><rec-number>31</rec-number><foreign-keys><key app="EN" db-id="ew9apwdzc05eeeeespxv52fn9tz0xzx00zrt">31</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Denning, D. W.</author><author>Stevens, D. A.</author></authors></contributors><auth-address>Department of Medicine, Santa Clara Valley Medical Center, San Jose, California 95128.</auth-address><titles><title>Antifungal and surgical treatment of invasive aspergillosis: review of 2,121 published cases</title><secondary-title>Rev Infect Dis</secondary-title><alt-title>Reviews of infectious diseases</alt-title></titles><periodical><full-title>Rev Infect Dis</full-title><abbr-1>Reviews of infectious diseases</abbr-1></periodical><alt-periodical><full-title>Rev Infect Dis</full-title><abbr-1>Reviews of infectious diseases</abbr-1></alt-periodical><pages>1147-201</pages><volume>12</volume><number>6</number><keywords><keyword>Amphotericin B/therapeutic use</keyword><keyword>Animals</keyword><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Aspergillosis/*drug therapy/surgery</keyword><keyword>Disease Models, Animal</keyword><keyword>Flucytosine/therapeutic use</keyword><keyword>Humans</keyword></keywords><dates><year>1990</year><pub-dates><date>Nov-Dec</date></pub-dates></dates><isbn>0162-0886 (Print)&#xD;0162-0886 (Linking)</isbn><accession-num>2267490</accession-num><urls><related-urls><url>;[424]. Invasive TBA is an uncommon disease that originates in the airway, but may invade more deeply PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZW1wZXI8L0F1dGhvcj48WWVhcj4xOTkzPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [422, 425]. It has been described most commonly in immunosuppressed patients (hematologic malignancies, lung or HSCT recipients, and patients on high dose steroids). However, invasive TBA among patients with no known immunosuppression or following influenza infection has also been described PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb290czwvQXV0aG9yPjxZZWFyPjE5OTk8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [422, 428]. These two forms may represent different states of the same disease process that involves Aspergillus invasion of the tracheal or bronchial mucosa, which can extend into the cartilage. The ulcerative form is characterized by discrete ulcerative or plaque-like lesions in the bronchial wall. This form is most commonly observed in lung transplant recipients or patients with AIDS PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LcmVua2U8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [422, 428]. The pseudomembranous form is characterized by extensive membranes overlying the tracheal or bronchial mucosal surface. It most commonly reported in severely immunocompromised patients with hematologic malignancies or those HSCT recipients with GVHD. Rarely, it has been linked to post-influenza syndrome. In general, the ulcerative form carries a better prognosis than the pseudomembranous form. Treatment includes systemic antifungal therapy with a mould-active triazole agent or a lipid formulation of AmB. Follow-up bronchoscopy might be necessary to follow progression. Repeated bronchoscopies might be indicated for clearance of pseudomembranes and/or mucous plugs. The procedure might be complicated by bleeding, especially in the setting of necrotizing pseudomembranes with extension into pulmonary vessels, and should be performed by experienced interventional bronchoscopists. TBA is most commonly described in lung transplant recipients, affecting 4 to 6% of patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LcmFtZXI8L0F1dGhvcj48WWVhcj4xOTkxPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [430] . TBA typically occurs within 3 to 6 months of lung transplantation, presumably as a result of airway ischemia due to disruption of bronchial vasculature during the transplant procedure. Furthermore, ischemic reperfusion injury might lead to airway stricture and other abnormalities that predispose to Aspergillus colonization and disease. Most lesions are asymptomatic and diagnosed by surveillance bronchoscopy; they manifest as pseudomembranes, ulceration, black eschar or plaques. Rare cases of obstructing bronchial aspergillosis and TBA with bronchopleural fistulae have also been described. These lesions can develop despite systemic antifungal prophylaxis. Although TBA can progress to involve the lungs and disseminate, the overall outcome is better than IPA. Improved outcomes might result from early diagnosis based on surveillance bronchoscopy that is routinely performed in lung transplantation. We recommend an anti-mould triazole or intravenous lipid formulation of AmB based on case series. If the lesion develops while on antifungal prophylaxis, optimization of antifungal dosing with TDM is indicated. We also recommend adjunctive aerosolized amphotericin B as the anastomotic site is devascularized making it difficult for parenteral therapies to achieve therapeutic concentrations.?Pseudomembranous TBA might be adjunctively treated with bronchoscopic debridement. Airway stenosis resulting from TBA might require balloon dilation, laser treatment or stent placement. Endobronchial TBA with anastomotic dehiscence might need stent placement or surgical repair ADDIN EN.CITE <EndNote><Cite><Author>Horvath</Author><Year>1993</Year><RecNum>34</RecNum><DisplayText>[431]</DisplayText><record><rec-number>34</rec-number><foreign-keys><key app="EN" db-id="ew9apwdzc05eeeeespxv52fn9tz0xzx00zrt">34</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Horvath, J.</author><author>Dummer, S.</author><author>Loyd, J.</author><author>Walker, B.</author><author>Merrill, W. H.</author><author>Frist, W. H.</author></authors></contributors><auth-address>Department of Surgery, Vanderbilt University School of Medicine, Nashville 37232.</auth-address><titles><title>Infection in the transplanted and native lung after single lung transplantation</title><secondary-title>Chest</secondary-title><alt-title>Chest</alt-title></titles><periodical><full-title>Chest</full-title><abbr-1>Chest</abbr-1></periodical><alt-periodical><full-title>Chest</full-title><abbr-1>Chest</abbr-1></alt-periodical><pages>681-5</pages><volume>104</volume><number>3</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Child</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infection/*etiology</keyword><keyword>*Lung Transplantation</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>*Postoperative Complications</keyword><keyword>Risk Factors</keyword></keywords><dates><year>1993</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>0012-3692 (Print)&#xD;0012-3692 (Linking)</isbn><accession-num>8365275</accession-num><urls><related-urls><url>;[431].?Duration of therapy for TBA is not well studied, but we recommend at least 3 months of systemic antifungal therapy with or without aerosolized AmB or until TBA is completely resolved, whichever is longer. MANAGEMENT OF EXTRAPULMONARY ASPERGILLOSISWhat are the treatment considerations for CNS aspergillosis?Recommendation50.We recommend voriconazole as primary therapy for CNS aspergillosis (Strong Recommendation; Moderate Quality Evidence). Lipid formulations of AmB are reserved for those intolerant or refractory to voriconazole (Strong Recommendation; Moderate Quality Evidence).Evidence summaryCNS aspergillosis is a devastating complication with a poor prognosis in the vast majority of affected patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MaW48L0F1dGhvcj48WWVhcj4yMDAxPC9ZZWFyPjxSZWNO

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ADDIN EN.CITE.DATA [432]. Tenets of management include attempts to establish an early diagnosis, administration of an appropriate antifungal agent, assessment of the need for surgical intervention, and attempts to mitigate immunologic impairment(s) that led to CNS aspergillosis ADDIN EN.CITE <EndNote><Cite><Author>McCarthy</Author><Year>2014</Year><RecNum>196</RecNum><DisplayText>[433]</DisplayText><record><rec-number>196</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413568110">196</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>McCarthy, M.</author><author>Rosengart, A.</author><author>Schuetz, A. N.</author><author>Kontoyiannis, D. P.</author><author>Walsh, T. J.</author></authors></contributors><auth-address>From the Transplantation-Oncology Infectious Diseases Program, Departments of Medicine, Pediatrics, and Microbiology and Immunology (M.M., T.J.W.), and the Departments of Neurology, Neuroscience, and Neurosurgery (A.R.) and Pathology and Laboratory Medicine (A.N.S.), Weill Cornell Medical Center of Cornell University, New York; and the Infectious Diseases Department and Division of Internal Medicine, University of Texas M.D. Anderson Cancer Center, Houston (D.P.K.).</auth-address><titles><title>Mold infections of the central nervous system</title><secondary-title>N Engl J Med</secondary-title><alt-title>The New England journal of medicine</alt-title></titles><periodical><full-title>New England Journal of Medicine</full-title><abbr-1>N. Engl. J. Med.</abbr-1><abbr-2>N Engl J Med</abbr-2></periodical><pages>150-60</pages><volume>371</volume><number>2</number><keywords><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>*Central Nervous System Fungal Infections/diagnosis/drug</keyword><keyword>therapy/immunology/surgery</keyword><keyword>Early Diagnosis</keyword><keyword>*Fungi</keyword><keyword>Humans</keyword></keywords><dates><year>2014</year><pub-dates><date>Jul 10</date></pub-dates></dates><isbn>1533-4406 (Electronic)&#xD;0028-4793 (Linking)</isbn><accession-num>25006721</accession-num><urls><related-urls><url>;[433]. Diagnosis is suggested by the presence of focal neurologic deficits or seizures in the immunocompromised host, while meningeal signs are uncommon. CT and MRI are essential for the detection of infection and monitoring response to therapy. The radiographic pattern is dependent on the source of infection with direct extension from the sinuses, eye or middle ear often causing only a single abscess within the frontal or temporal lobe, and those developing from hematogenous dissemination causing solitary or multiple small abscesses most frequently at the gray-white junction. Vascular invasion may occur and rupture with the development of a hemorrhagic or ischemic stroke, subarachnoid hemorrhage, or empyema formation. Definitive diagnosis is dependent on recovery of the organism, or examination of biopsy findings. Biopsy of lesions within the CNS is not always practical and infection of the CNS is commonly inferred by recovery of Aspergillus spp. from a pulmonary or sinus source coincident with a characteristic brain lesion. The value of screening patients with IPA for asymptomatic CNS disease has not been determined. Detection of GM PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WaXNjb2xpPC9BdXRob3I+PFllYXI+MjAwMjwvWWVhcj48

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ADDIN EN.CITE.DATA [434] or (1→3)-β-D-glucan from the cerebrospinal fluid (CSF) ADDIN EN.CITE <EndNote><Cite><Author>Mikulska</Author><Year>2013</Year><RecNum>200</RecNum><DisplayText>[435]</DisplayText><record><rec-number>200</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413568765">200</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mikulska, M.</author><author>Furfaro, E.</author><author>Del Bono, V.</author><author>Raiola, A. M.</author><author>Di Grazia, C.</author><author>Bacigalupo, A.</author><author>Viscoli, C.</author></authors></contributors><titles><title>(1-3)-beta-D-glucan in cerebrospinal fluid is useful for the diagnosis of central nervous system fungal infections</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>1511-2</pages><volume>56</volume><number>10</number><keywords><keyword>Adult</keyword><keyword>Biological Markers/blood/cerebrospinal fluid</keyword><keyword>Central Nervous System Fungal Infections/blood/*cerebrospinal fluid/microbiology</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>beta-Glucans/blood/*cerebrospinal fluid</keyword></keywords><dates><year>2013</year><pub-dates><date>May</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>23392391</accession-num><urls><related-urls><url>;[435] is helpful in the diagnosis of CNS aspergillosis, however other fungal pathogens also have positive results with these assays (e.g., Fusarium spp.) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ub3J0b3Jhbm88L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFy

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ADDIN EN.CITE.DATA [436]. PCR assays have been examined for CNS aspergillosis, however these have not been standardized for widespread use PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SZWlud2FsZDwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+

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ADDIN EN.CITE.DATA [87]. Surgical intervention is frequently discussed during the care of patients with CNS aspergillosis as resection of infected tissue or abscesses eliminates areas containing viable fungi. A mortality benefit of surgery for the management of cerebral lesions, in combination with antifungal therapy with voriconazole, has been shown in a retrospective study of 81 patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2h3YXJ0ejwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+

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ADDIN EN.CITE.DATA [437]. Although this study was subject to selection bias for those patients who were ultimately able to undergo surgical intervention, a benefit of voriconazole followed by surgical intervention was suggested (Hazard Ratio, 2.1; 95% Confidence Interval 1.1,3.9, p=0.2). Surgical intervention is also a useful adjunct in the management of CNS aspergillosis with contiguous infections of the paranasal sinuses, or vertebral bodies and should be pursued in these circumstances when feasible.The reversal or reduction of immunosuppression is essential in attempts to improve outcomes and should be managed in the same fashion as discussed elsewhere in this document. Recommendations for the treatment of CNS aspergillosis with voriconazole are based primarily on open-label studies. In a direct comparative trial between AmB deoxycholate and voriconazole, a trend toward improvement of CNS aspergillosis in patients was noted in those who were treated with voriconazole PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZXJicmVjaHQ8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFy

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ADDIN EN.CITE.DATA [218, 437]. It should be noted voriconazole interacts with some antiseizure medications (phenytoin, phenobarbital) that may be coadministered in patients with CNS mass lesions, likely resulting in sub-therapeutic concentrations.Lipid formulations of AmB have demonstrated favorable responses in animal models and patients with CNS aspergillosis. Among lipid formulations of AmB formulations, favorable responses have been achieved in case reports with liposomal AmB, ABLC, and ABCD PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZzwvQXV0aG9yPjxZZWFyPjIwMDA8L1llYXI+PFJlY051

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ADDIN EN.CITE.DATA [438-440]. Itraconazole and posaconazole have also been successfully used in treatment of CNS aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QaXRpc3V0dGl0aHVtPC9BdXRob3I+PFllYXI+MjAwNTwv

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ADDIN EN.CITE.DATA [257, 441, 442] and case reports describe the efficacy of caspofungin and micafungin in the treatment of CNS aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWVydGVuczwvQXV0aG9yPjxZZWFyPjIwMDQ8L1llYXI+

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ADDIN EN.CITE.DATA [400, 443]. Combination therapy for CNS disease is initiated by some practitioners out of understandable lack of therapeutic options given the mortality associated with this form of dissemination, and a favorable response has been observed in animal models and some patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWVydGVuczwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+

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ADDIN EN.CITE.DATA [199], yet there are no data suggesting better outcomes with this approach. Progressive neurologic deficits have led to the use of corticosteroid therapy in patients with evolving CNS disease, however this practice is deleterious and should be avoided. Intrathecal or intralesional antifungal therapy is also not recommended for the treatment of CNS aspergillosis due to a failure of AMB delivered intrathecally to penetrate beyond the pia mater. Delivery via this method also has the potential for AMB-induced chemical meningitis, arachnoiditis, seizures, headache or altered mental status ADDIN EN.CITE <EndNote><Cite><Author>Stevens</Author><Year>2001</Year><RecNum>212</RecNum><DisplayText>[444]</DisplayText><record><rec-number>212</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413584939">212</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Stevens, D. A.</author><author>Shatsky, S. A.</author></authors></contributors><auth-address>Division of Infectious Diseases, Department of Medicine, Santa Clara Valley Medical Center, San Jose, CA 95128-2699, USA. oflaherty@hhs.co.santa-clara.ca.us</auth-address><titles><title>Intrathecal amphotericin in the management of coccidioidal meningitis</title><secondary-title>Semin Respir Infect</secondary-title><alt-title>Seminars in respiratory infections</alt-title></titles><periodical><full-title>Seminars in Respiratory Infections</full-title><abbr-1>Semin. Respir. Infect.</abbr-1><abbr-2>Semin Respir Infect</abbr-2></periodical><alt-periodical><full-title>Seminars in Respiratory Infections</full-title><abbr-1>Semin. Respir. Infect.</abbr-1><abbr-2>Semin Respir Infect</abbr-2></alt-periodical><pages>263-9</pages><volume>16</volume><number>4</number><keywords><keyword>Amphotericin B/*administration &amp; dosage/therapeutic use</keyword><keyword>Antifungal Agents/*administration &amp; dosage/therapeutic use</keyword><keyword>Coccidioidomycosis/*drug therapy</keyword><keyword>Humans</keyword><keyword>Injections, Spinal</keyword><keyword>Instillation, Drug</keyword><keyword>Meningitis, Fungal/*drug therapy</keyword></keywords><dates><year>2001</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>0882-0546 (Print)&#xD;0882-0546 (Linking)</isbn><accession-num>11740828</accession-num><urls><related-urls><url>;[444].Epidural aspergillosis is an unusual manifestation of CNS aspergillosis that most often arises from extension into the epidural space from vertebral abscess ADDIN EN.CITE <EndNote><Cite><Author>Dubbeld</Author><Year>1996</Year><RecNum>213</RecNum><DisplayText>[445]</DisplayText><record><rec-number>213</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413585021">213</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dubbeld, P.</author><author>van Oostenbrugge, R. J.</author><author>Twinjstra, A.</author><author>Schouten, H. C.</author></authors></contributors><auth-address>Department of Internal Medicine, University Hospital, Maastricht, Netherlands.</auth-address><titles><title>Spinal epidural abscess due to Aspergillus infection of the vertebrae: report of 3 cases</title><secondary-title>Neth J Med</secondary-title><alt-title>The Netherlands journal of medicine</alt-title></titles><periodical><full-title>Netherlands Journal of Medicine</full-title><abbr-1>Neth. J. Med.</abbr-1><abbr-2>Neth J Med</abbr-2></periodical><pages>18-23</pages><volume>48</volume><number>1</number><keywords><keyword>Abscess/complications/diagnosis/*microbiology/therapy</keyword><keyword>Acute Disease</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>*Aspergillosis/complications/diagnosis/therapy</keyword><keyword>*Cervical Vertebrae</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Immunocompromised Host</keyword><keyword>Leukemia, Myeloid/*complications</keyword><keyword>*Lumbar Vertebrae</keyword><keyword>Male</keyword><keyword>Spinal Diseases/complications/diagnosis/microbiology/therapy</keyword></keywords><dates><year>1996</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>0300-2977 (Print)&#xD;0300-2977 (Linking)</isbn><accession-num>8775748</accession-num><urls><related-urls><url>;[445]. Systemic antifungal therapy and surgical drainage are considered to be standards of practice for management of epidural aspergillosis; however, most of the experience in managing epidural aspergillosis is based on individual case reports and brief case series. How is Aspergillus endophthalmitis treated?Recommendation51.We recommend that Aspergillus endophthalmitis be treated with systemic oral or intravenous voriconazole plus intravitreal voriconazole or intravitreal AmB deoxycholate (Strong Recommendation: Weak Quality Evidence).Evidence summaryHematogenous endophthalmitis presents in immunocompromised and noncompromised patients as sudden loss of vision, usually in one eye, beginning with subretinal lesions which cause retinal necrosis and rapidly extend into the vitreous humor ADDIN EN.CITE <EndNote><Cite><Author>Ng</Author><Year>2013</Year><RecNum>934</RecNum><DisplayText>[446]</DisplayText><record><rec-number>934</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454450017">934</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ng, J.</author><author>Ho, S.</author><author>Krishnan, P.</author><author>Teoh, S. C.</author></authors></contributors><titles><title>Aspergillus terreus endogenous endophthalmitis in a nonimmunocompromised patient with a history of bronchiectasis</title><secondary-title>Ocul Immunol Inflamm</secondary-title></titles><periodical><full-title>Ocular Immunology and Inflammation</full-title><abbr-1>Ocul. Immunol. Inflamm.</abbr-1><abbr-2>Ocul Immunol Inflamm</abbr-2><abbr-3>Ocular Immunology &amp; Inflammation</abbr-3></periodical><pages>231-3</pages><volume>21</volume><number>3</number><keywords><keyword>Adult</keyword><keyword>Aspergillosis/diagnosis/*etiology/microbiology</keyword><keyword>Aspergillus/*isolation &amp; purification</keyword><keyword>Biopsy</keyword><keyword>Bronchiectasis/*complications/diagnosis</keyword><keyword>Diagnosis, Differential</keyword><keyword>Endophthalmitis/diagnosis/*etiology/microbiology</keyword><keyword>Eye Infections, Fungal/diagnosis/*etiology/microbiology</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>*Immunocompromised Host</keyword><keyword>Vitreous Body/*microbiology</keyword></keywords><dates><year>2013</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1744-5078 (Electronic)&#xD;0927-3948 (Linking)</isbn><accession-num>23480607</accession-num><urls><related-urls><url>;[446]. A dense vitritis forms over a few days. A vitreal aspirate or vitrectomy specimen yields Aspergillus, usually Aspergillus fumigatus, on culture and smear ADDIN EN.CITE <EndNote><Cite><Author>Georgala</Author><Year>2011</Year><RecNum>137</RecNum><DisplayText>[447]</DisplayText><record><rec-number>137</rec-number><foreign-keys><key app="EN" db-id="wz22tapswre00oese5y59zx80zevz2r905e0" timestamp="1403179404">137</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Georgala, A.</author><author>Layeux, B.</author><author>Kwan, J.</author><author>Ahmad, I.</author><author>Libert, J.</author><author>Willermain, F.</author><author>Koch, P.</author><author>Heymans, C.</author><author>Husson, M.</author><author>Aoun, M.</author></authors></contributors><titles><title>Inaugural bilateral aspergillus endophthalmitis in a seriously immunocompromised patient</title><secondary-title>Mycoses</secondary-title><alt-title>Mycoses</alt-title></titles><periodical><full-title>Mycoses</full-title><abbr-1>Mycoses</abbr-1></periodical><alt-periodical><full-title>Mycoses</full-title><abbr-1>Mycoses</abbr-1></alt-periodical><pages>e631-3</pages><volume>54</volume><number>5</number><keywords><keyword>Adult</keyword><keyword>Aspergillosis/*diagnosis/microbiology/*pathology</keyword><keyword>Aspergillus/*isolation &amp; purification</keyword><keyword>Endophthalmitis/*diagnosis/microbiology/*pathology</keyword><keyword>Eye/microbiology/pathology</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Immunocompromised Host</keyword><keyword>Microscopy, Electron</keyword><keyword>Microscopy, Fluorescence</keyword><keyword>Retina/pathology</keyword><keyword>Vitreous Body/microbiology</keyword></keywords><dates><year>2011</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1439-0507 (Electronic)&#xD;0933-7407 (Linking)</isbn><accession-num>21039938</accession-num><urls><related-urls><url>;[447]. 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ADDIN EN.CITE.DATA [448]. Local concentration of drug is lower if intravitreal drug is injected at the end of a pars plana vitrectomy, lessening concern about retinal toxicity of AmB deoxycholate when that drug is used. Although intracameral injection (injection into the anterior chamber) has no role in aspergillosis of the posterior chamber, it has been reported that intracameral injection of voriconazole 100 ?g was useful for extension of Aspergillus keratitis into the anterior chamber PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGVuPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [449]. What is the role of surgery in aspergillosis of the paranasal sinuses?Recommendation52.We recommend that both surgery and either systemic voriconazole or a lipid formulation of AmB formulation be used in invasive Aspergillus fungal sinusitis but that surgical removal alone can be used to treat Aspergillus fungal ball of the paranasal sinus. Enlargement of the sinus ostomy may be needed to improve drainage and prevent recurrence (Strong Recommendation; Moderate Quality Evidence).Evidence summaryIn uncomplicated Aspergillus fungal ball of the sinus, >90% being in the maxillary sinus, clinicians should remove the fungal ball, preferably using endoscopic techniques as this is usually curative. A wide maxillary antrostomy is done to improve sinus drainage and a biopsy of the sinus wall is sometimes done to rule out mucosal invasion PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Hcm9zamVhbjwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+

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AG==

ADDIN EN.CITE.DATA [450-452]. Local or systemic antifungals have no role in the treatment of a maxillary sinus fungal ball. Aspergillus fungal balls of the sphenoid sinus differ in that invasion into the cavernous sinus can occur from fungal invasion or excessive surgical debridement ADDIN EN.CITE <EndNote><Cite><Author>Karkas</Author><Year>2013</Year><RecNum>336</RecNum><DisplayText>[453]</DisplayText><record><rec-number>336</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1416522530">336</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Karkas, A.</author><author>Rtail, R.</author><author>Reyt, E.</author><author>Timi, N.</author><author>Righini, C. A.</author></authors></contributors><auth-address>Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Grenoble, PO Box 217, 38043, Grenoble Cedex 9, France. akarkas@chu-grenoble.fr</auth-address><titles><title>Sphenoid sinus fungus ball</title><secondary-title>Eur Arch Otorhinolaryngol</secondary-title><alt-title>European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies</alt-title></titles><periodical><full-title>European Archives of Oto-Rhino-Laryngology</full-title><abbr-1>Eur. Arch. Otorhinolaryngol.</abbr-1><abbr-2>Eur Arch Otorhinolaryngol</abbr-2></periodical><pages>893-8</pages><volume>270</volume><number>3</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>Aspergillosis/*diagnosis/surgery</keyword><keyword>Endoscopy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Magnetic Resonance Imaging</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Retrospective Studies</keyword><keyword>Sphenoid Sinusitis/*diagnosis/surgery</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2013</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1434-4726 (Electronic)&#xD;0937-4477 (Linking)</isbn><accession-num>22850907</accession-num><urls><related-urls><url>;[453]. Systemic antifungal therapy may be advisable if there is a question of mucosal involvement, mucosal breach of the sphenoid sinus, or spread into the cavernous sinus. Local irrigation of the paranasal sinuses with amphotericin B is not considered useful because topical amphotericin B does not penetrate into tissues. In granulomatous or chronic invasive and granulomatous aspergillosis of the paranasal sinus in immunocompetent patients, often diagnosed because of proptosis or extension to the brain or orbit, and in acute invasive paranasal sinusitis of severely immunocompromised patients, surgical debridement and systemic antifungal therapy is recommended. Sometimes multiple surgical procedures are required, and extensive debridement is best done once thrombocytopenia has resolved, to reduce the risk of post-operative hemorrhage. Voriconazole is the preferred therapy, or a lipid formulation of AmB; morbidity and mortality is high PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaWRkaXF1aTwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+

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ADDIN EN.CITE.DATA [454-456]. Allergic fungal rhinosinusitis is discussed elsewhere.What are the treatment recommendations for Aspergillus endocarditis, pericarditis, and myocarditis?Recommendation53.In Aspergillus endocarditis, we recommend early surgical intervention combined with antifungal therapy in attempts to prevent embolic complications and valvular decompensation (Strong Recommendation; Moderate Quality Evidence). Voriconazole or a lipid formulation of AmB is recommended as initial therapy (Strong Recommendation; Low Quality Evidence). Following surgical replacement of an infected valve, lifelong antifungal therapy should be considered (Strong Recommendation; Low Quality Evidence).Evidence summaryThe diagnosis of Aspergillus endocarditis is often difficult and almost always delayed with the diagnosis made post-mortem in up to one-third of cases PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NY0Nvcm1hY2s8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFy

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ADDIN EN.CITE.DATA [457]. Fever, the presence of a new murmur, and stigmata of peripheral emboli such as new neurologic deficits, heart failure, or dyspnea are the most commonly encountered clinical features and no different from those observed in bacterial endocarditis. Blood cultures are almost always negative, and examination of resected valvular tissue or emboli is the most common means of confirming the diagnosis. The converse is not true; positive blood cultures are more likely to be contaminants than indicating endocarditis. Non-invasive markers such as GM may be positive, however are not specific for the site of disease ADDIN EN.CITE <EndNote><Cite><Author>Riviere</Author><Year>2013</Year><RecNum>293</RecNum><DisplayText>[458]</DisplayText><record><rec-number>293</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415046355">293</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Riviere, S.</author><author>Lortholary, O.</author><author>Michon, J.</author><author>Bougnoux, M. E.</author><author>Mainardi, J. L.</author><author>Sendid, B.</author><author>Bretagne, S.</author><author>Lefort, A.</author></authors></contributors><titles><title>Aspergillus endocarditis in the era of new antifungals: major role for antigen detection</title><secondary-title>J Infect</secondary-title><alt-title>The Journal of infection</alt-title></titles><periodical><full-title>Journal of Infection</full-title><abbr-1>J. Infect.</abbr-1><abbr-2>J Infect</abbr-2></periodical><pages>85-8</pages><volume>67</volume><number>1</number><keywords><keyword>Aspergillosis/*epidemiology/*therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword></keywords><dates><year>2013</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1532-2742 (Electronic)&#xD;0163-4453 (Linking)</isbn><accession-num>23384559</accession-num><urls><related-urls><url>;[458].The aortic and mitral valves are those most frequently infected. Prior valvular abnormalities and/or prior valvular surgery predisposes to infection, although intravenous drug use and other cardiac procedures have also been presented as predisposing factors. Vegetations secondary to Aspergillus spp. are often large and/or penduculated and therefore embolic complications are common, particularly to large arteries. For this reason, imaging of the brain is prudent at the time of diagnosis in attempts to define the full spectrum of disease. Mortality rates are high (50-96%). The mean survival period for Aspergillus endocarditis was 11 days in one study, further illustrating the rapid and frequently lethal course of this infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FbGxpczwvQXV0aG9yPjxZZWFyPjIwMDE8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [424, 460] and attempts to manage patients with antifungal agents alone are rarely successful. Voriconazole or liposomal AmB (3-5 mg/kg/day) are recommended as first-line agents. Comparative data is not available, however case reports ADDIN EN.CITE <EndNote><Cite><Author>Reis</Author><Year>2005</Year><RecNum>295</RecNum><DisplayText>[461]</DisplayText><record><rec-number>295</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415746421">295</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Reis, L. J.</author><author>Barton, T. D.</author><author>Pochettino, A.</author><author>Velazquez, O.</author><author>McGarvey, M.</author><author>Milas, B.</author><author>Reboli, A.</author><author>Schuster, M. G.</author></authors></contributors><auth-address>Hospital of The University of Pennsylvania, Philadelphia, PA, USA.</auth-address><titles><title>Successful treatment of Aspergillus prosthetic valve endocarditis with oral voriconazole</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>752-3</pages><volume>41</volume><number>5</number><keywords><keyword>Adult</keyword><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Aspergillosis/*drug therapy</keyword><keyword>Endocarditis/*drug therapy/*microbiology</keyword><keyword>Heart Valve Prosthesis/*microbiology</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Pyrimidines/*therapeutic use</keyword><keyword>Triazoles/*therapeutic use</keyword></keywords><dates><year>2005</year><pub-dates><date>Sep 1</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>16080100</accession-num><urls><related-urls><url>;[461], case series PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NY0Nvcm1hY2s8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFy

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ADDIN EN.CITE.DATA [462] have suggested the efficacy of these agents in Aspergillus IE. Combination therapy may also be used but no evidence regarding the superiority of this approach has been presented. The overall poor survival of IE secondary to Aspergillus spp. limits the available data on recurrence rates. In other causes of fungal endocarditis, recurrence may occur late and even years after the initial diagnosis. For this reason, long durations of therapy (>2 years) and consideration of lifelong therapy should be considered concomitant with frequent clinical and echocardiographic assessment for possible recurrence PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NY0Nvcm1hY2s8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFy

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ADDIN EN.CITE.DATA [463, 464]. Pericardial tamponade may rapidly ensue, leading to hemodynamic deterioration and cardiac arrest. Diagnosis is suggested by pericardiocentesis (with positive culture or antigen testing), pericardiectomy, or pericardial biopsy. A combined medical and surgical approach, with pericardial resection or drainage, is necessary in attempts to optimize outcomes ADDIN EN.CITE <EndNote><Cite><Author>Le Moing</Author><Year>1998</Year><RecNum>300</RecNum><DisplayText>[464]</DisplayText><record><rec-number>300</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415749179">300</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Le Moing, V.</author><author>Lortholary, O.</author><author>Timsit, J. F.</author><author>Couvelard, A.</author><author>Bouges-Michel, C.</author><author>Wolff, M.</author><author>Guillevin, L.</author><author>Casassus, P.</author></authors></contributors><auth-address>Department of Internal Medicine, Hopital Avicenne, Universite Paris-Nord, Bobigny, France.</auth-address><titles><title>Aspergillus pericarditis with tamponade: report of a successfully treated case and review</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>451-60</pages><volume>26</volume><number>2</number><keywords><keyword>Adult</keyword><keyword>Aspergillosis/complications/pathology/physiopathology/*therapy</keyword><keyword>Cardiac Tamponade/*complications</keyword><keyword>Fatal Outcome</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Pericarditis/complications/pathology/physiopathology/*therapy</keyword></keywords><dates><year>1998</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1058-4838 (Print)&#xD;1058-4838 (Linking)</isbn><accession-num>9502470</accession-num><urls><related-urls><url>;[464]. Aspergillus myocarditis may manifest as myocardial infarction, cardiac dysrhythmias, or myoepicarditis ADDIN EN.CITE <EndNote><Cite><Author>Walsh</Author><Year>1982</Year><RecNum>299</RecNum><DisplayText>[463]</DisplayText><record><rec-number>299</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415748792">299</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Walsh, T. J.</author><author>Bulkley, B. H.</author></authors></contributors><titles><title>Aspergillus pericarditis: clinical and pathologic features in the immunocompromised patient</title><secondary-title>Cancer</secondary-title><alt-title>Cancer</alt-title></titles><periodical><full-title>Cancer</full-title><abbr-1>Cancer</abbr-1><abbr-2>Cancer</abbr-2></periodical><alt-periodical><full-title>Cancer</full-title><abbr-1>Cancer</abbr-1><abbr-2>Cancer</abbr-2></alt-periodical><pages>48-54</pages><volume>49</volume><number>1</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aspergillosis/immunology/*microbiology/pathology</keyword><keyword>Aspergillus flavus/isolation &amp; purification</keyword><keyword>Cardiac Tamponade/etiology</keyword><keyword>Electrocardiography</keyword><keyword>Female</keyword><keyword>Heart/microbiology/radiography</keyword><keyword>Humans</keyword><keyword>Leukemia/complications/immunology</keyword><keyword>Lung/microbiology/radiography</keyword><keyword>Lung Diseases, Fungal/complications/*microbiology</keyword><keyword>Middle Aged</keyword><keyword>Myocardium/pathology</keyword><keyword>Pericarditis/immunology/*microbiology/pathology</keyword><keyword>Pericardium/microbiology/pathology</keyword><keyword>Pleural Effusion/etiology</keyword></keywords><dates><year>1982</year><pub-dates><date>Jan 1</date></pub-dates></dates><isbn>0008-543X (Print)&#xD;0008-543X (Linking)</isbn><accession-num>6797718</accession-num><urls><related-urls><url>;[463]. This infection generally occurs in the context of disseminated disease and requires systemic antifungal therapy. An intracardiac abscess may be seen on echocardiography, although in other cases no echocardiographic lesions are observed PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SdWV0ZXI8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [465]. What are the treatment recommendations for Aspergillus osteomyelitis and septic arthritis?Recommendation54.Surgical intervention is recommended, where feasible, for management of Aspergillus osteomyelitis and arthritis, combined with voriconazole (Strong Recommendation; Moderate Quality Evidence).Evidence summaryAspergillus osteomyelitis occurs by one of three mechanisms: (1) direct inoculation secondary to trauma, surgery, or epidural injection; (2) contiguous spread from pleuropulmonary disease; or (3) hematogenous spread from either coexistent pulmonary infection or intravenous injection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdHVkZW1laXN0ZXI8L0F1dGhvcj48WWVhcj4yMDExPC9Z

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ADDIN EN.CITE.DATA [466, 467]. Most patients have traditional risk factors for IA, however up to 34% of patients have no obvious predisposing factor or immunosuppression ADDIN EN.CITE <EndNote><Cite><Author>Vinas</Author><Year>1999</Year><RecNum>305</RecNum><DisplayText>[468]</DisplayText><record><rec-number>305</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415814947">305</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Vinas, F. C.</author><author>King, P. K.</author><author>Diaz, F. G.</author></authors></contributors><auth-address>Department of Neurological Surgery, Wayne State University School of Medicine, Detroit, Michigan 48201, USA. vinas@neurosurg.wayne.edu</auth-address><titles><title>Spinal aspergillus osteomyelitis</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>1223-9</pages><volume>28</volume><number>6</number><keywords><keyword>Adult</keyword><keyword>Aspergillosis/*diagnosis/etiology/therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Osteomyelitis/*diagnosis/etiology/therapy</keyword><keyword>Spinal Diseases/*diagnosis/etiology/therapy</keyword></keywords><dates><year>1999</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1058-4838 (Print)&#xD;1058-4838 (Linking)</isbn><accession-num>10451157</accession-num><urls><related-urls><url>;[468]. Vertebral osteomyelitis with or without discitis is the most common form and the predominance of cases involve the lumbar vertebrae. Back pain is the most common clinical manifestation, with neurologic deficits secondary to cord compromise, or kyphosis also observed. Diagnostic imaging with CT and/or MRI is essential for staging disease and for providing a guide for orthopedic and/or neurosurgical intervention. Diagnosis can be confirmed by isolation of the organism from bone specimens or an aspirate of an adjacent fluid collection. In cases without significant instability or neural compression and no evidence of disease progression, antifungal treatment alone may be sufficient provided the underlying immunologic deficit can be corrected, however it should be noted favorable outcomes more frequently occur in those receiving combined medical and surgical therapy ADDIN EN.CITE <EndNote><Cite><Author>Studemeister</Author><Year>2011</Year><RecNum>303</RecNum><DisplayText>[466]</DisplayText><record><rec-number>303</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415814845">303</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Studemeister, A.</author><author>Stevens, D. A.</author></authors></contributors><auth-address>Division of Infectious Diseases, San Jose Medical Group, San Jose, Carlifornia, USA.</auth-address><titles><title>Aspergillus vertebral osteomyelitis in immunocompetent hosts: role of triazole antifungal therapy</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>e1-6</pages><volume>52</volume><number>1</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Aspergillosis/*diagnosis/microbiology</keyword><keyword>Aspergillus fumigatus/*isolation &amp; purification</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Osteomyelitis/*microbiology/*pathology</keyword><keyword>Spondylitis/*microbiology/*pathology</keyword><keyword>Treatment Outcome</keyword><keyword>Triazoles/therapeutic use</keyword></keywords><dates><year>2011</year><pub-dates><date>Jan 1</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>21148508</accession-num><urls><related-urls><url>;[466]. In cases with spinal instability or symptoms consistent with spinal cord or radicular compression or abscess formation, surgical decompression in combination with antifungal therapy is recommended ADDIN EN.CITE <EndNote><Cite><Author>Vinas</Author><Year>1999</Year><RecNum>305</RecNum><DisplayText>[468]</DisplayText><record><rec-number>305</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415814947">305</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Vinas, F. C.</author><author>King, P. K.</author><author>Diaz, F. G.</author></authors></contributors><auth-address>Department of Neurological Surgery, Wayne State University School of Medicine, Detroit, Michigan 48201, USA. vinas@neurosurg.wayne.edu</auth-address><titles><title>Spinal aspergillus osteomyelitis</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>1223-9</pages><volume>28</volume><number>6</number><keywords><keyword>Adult</keyword><keyword>Aspergillosis/*diagnosis/etiology/therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Osteomyelitis/*diagnosis/etiology/therapy</keyword><keyword>Spinal Diseases/*diagnosis/etiology/therapy</keyword></keywords><dates><year>1999</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1058-4838 (Print)&#xD;1058-4838 (Linking)</isbn><accession-num>10451157</accession-num><urls><related-urls><url>;[468]. The type and extent of surgery should be individualized. Voriconazole has been successfully used as salvage and primary therapy either alone or in combination with surgical debridement PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3VhczwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [469, 470] and has been shown superior to AmB in cases of disseminated aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZXJicmVjaHQ8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFy

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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZXJicmVjaHQ8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFy

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ADDIN EN.CITE.DATA [350]. Historical experience has shown the efficacy of AmB formulations. Itraconazole has been used subsequent to a course of AmB. There is little reported experience in the use of posaconazole or echinocandins in the treatment of Aspergillus osteomyelitis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib2RpYW1vbnQ8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFy

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ADDIN EN.CITE.DATA [466, 467]. Aspergillus arthritis may develop from hematogenous dissemination in immunocompromised patients, via injection, or by direct traumatic inoculation in immunocompetent hosts PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdW1hc2hpPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [472]. Most of the successfully treated cases of Aspergillus arthritis have responded to combined medical therapy and drainage of the joint and/or synovectomy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaXJieTwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [473]. Historically, AmB formulations have demonstrated efficacy in cases of arthritis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LdW1hc2hpPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48

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ADDIN EN.CITE.DATA [472], although more recent data has shown an improvement in response rates when voriconazole is administered, which is the recommended antifungal agent in this setting ADDIN EN.CITE <EndNote><Cite><Author>Koehler</Author><Year>2014</Year><RecNum>313</RecNum><DisplayText>[474]</DisplayText><record><rec-number>313</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1415821398">313</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Koehler, P.</author><author>Tacke, D.</author><author>Cornely, O. A.</author></authors></contributors><auth-address>1st Department of Internal Medicine, University Hospital of Cologne, Zentrum fur Klinische Studien (BMBF 01KN1106), CECAD - Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases, Cologne, Germany.</auth-address><titles><title>Aspergillosis of bones and joints - a review from 2002 until today</title><secondary-title>Mycoses</secondary-title><alt-title>Mycoses</alt-title></titles><periodical><full-title>Mycoses</full-title><abbr-1>Mycoses</abbr-1><abbr-2>Mycoses</abbr-2></periodical><alt-periodical><full-title>Mycoses</full-title><abbr-1>Mycoses</abbr-1><abbr-2>Mycoses</abbr-2></alt-periodical><pages>323-35</pages><volume>57</volume><number>6</number><dates><year>2014</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1439-0507 (Electronic)&#xD;0933-7407 (Linking)</isbn><accession-num>24397460</accession-num><urls><related-urls><url>;[474]. What are the treatment recommendations for cutaneous aspergillosis? Recommendations55.As cutaneous lesions may reflect disseminated infection, we recommend treatment with voriconazole in addition to evaluation for a primary focus of infection (Strong Recommendation; Low Quality Evidence). 56.In cases of aspergillosis in burns or massive soft tissue wounds, surgical debridement is recommended, in addition to antifungal therapy (Strong Recommendation; Moderate Quality Evidence). Evidence summaryCutaneous aspergillosis may develop in the context of hematogenous dissemination in the immunocompromised host or can occur in the context of traumatic or nosocomial device-related infection, or burn victims and represents a heterogeneous disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CcnljZTwvQXV0aG9yPjxZZWFyPjE5OTY8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [11, 475, 476]. The initial lesions of cutaneous aspergillosis may appear as macules, papules, nodules, or plaques. Pustules or lesions with purulent discharge generally occur in neonates ADDIN EN.CITE <EndNote><Cite><Author>van Burik</Author><Year>1998</Year><RecNum>790</RecNum><DisplayText>[9]</DisplayText><record><rec-number>790</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454359780">790</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>van Burik, J. A.</author><author>Colven, R.</author><author>Spach, D. H.</author></authors></contributors><auth-address>Department of Medicine, Division of Allergy and Infectious Diseases, Seattle, Washington, USA. jvanburi@</auth-address><titles><title>Cutaneous aspergillosis</title><secondary-title>J Clin Microbiol</secondary-title></titles><periodical><full-title>Journal of Clinical Microbiology</full-title><abbr-1>J. Clin. Microbiol.</abbr-1><abbr-2>J Clin Microbiol</abbr-2></periodical><pages>3115-21</pages><volume>36</volume><number>11</number><keywords><keyword>AIDS-Related Opportunistic Infections/diagnosis/etiology/therapy</keyword><keyword>Aspergillosis/diagnosis/*etiology/therapy</keyword><keyword>Aspergillus/isolation &amp; purification</keyword><keyword>Bone Marrow Transplantation/adverse effects</keyword><keyword>Burns/complications</keyword><keyword>Dermatomycoses/diagnosis/*etiology/therapy</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>Neoplasms/complications</keyword><keyword>Organ Transplantation/adverse effects</keyword></keywords><dates><year>1998</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>0095-1137 (Print)&#xD;0095-1137 (Linking)</isbn><accession-num>9774549</accession-num><urls><related-urls><url>;[9]. Unlike IPA, which requires thoracic surgery or thoracoscopy to remove foci of infection, the eradication of cutaneous aspergillosis may be accomplished with considerably less risk ADDIN EN.CITE <EndNote><Cite><Author>Walsh</Author><Year>1998</Year><RecNum>942</RecNum><DisplayText>[477]</DisplayText><record><rec-number>942</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454450498">942</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Walsh, T. J.</author></authors></contributors><titles><title>Primary cutaneous aspergillosis--an emerging infection among immunocompromised patients</title><secondary-title>Clin Infect Dis</secondary-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>453-7</pages><volume>27</volume><number>3</number><keywords><keyword>AIDS-Related Opportunistic Infections/immunology/microbiology</keyword><keyword>Amphotericin B/therapeutic use</keyword><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Aspergillosis/drug therapy/*immunology/microbiology</keyword><keyword>Aspergillus/*immunology/isolation &amp; purification</keyword><keyword>Dermatomycoses/drug therapy/*immunology/microbiology</keyword><keyword>Humans</keyword><keyword>*Immunocompromised Host</keyword><keyword>Prognosis</keyword></keywords><dates><year>1998</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>1058-4838 (Print)&#xD;1058-4838 (Linking)</isbn><accession-num>9770139</accession-num><urls><related-urls><url>;[477]. Therefore, surgical intervention, for primary cutaneous infection, may be a useful adjunct to antifungal therapy. Biopsy for confirmation of mycological diagnosis is essential to distinguish aspergillosis from other potential pathogens (e.g., fusariosis, mucormycosis) ADDIN EN.CITE <EndNote><Cite><Author>Eldridge</Author><Year>2014</Year><RecNum>558</RecNum><DisplayText>[478]</DisplayText><record><rec-number>558</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1436216749">558</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Eldridge, M. L.</author><author>Chambers, C. J.</author><author>Sharon, V. R.</author><author>Thompson, G. R., 3rd</author></authors></contributors><auth-address>Department of Internal Medicine, Division of Infectious Diseases, University of California Davis Medical Center, 2315 Stockton Blvd, Sacramento, CA 95817, USA.</auth-address><titles><title>Fungal infections of the skin and nail: new treatment options</title><secondary-title>Expert Rev Anti Infect Ther</secondary-title><alt-title>Expert review of anti-infective therapy</alt-title></titles><periodical><full-title>Expert Review of Anti-Infective Therapy</full-title><abbr-1>Expert Rev. Anti Infect. Ther.</abbr-1><abbr-2>Expert Rev Anti Infect Ther</abbr-2></periodical><alt-periodical><full-title>Expert Review of Anti-Infective Therapy</full-title><abbr-1>Expert Rev. Anti Infect. Ther.</abbr-1><abbr-2>Expert Rev Anti Infect Ther</abbr-2></alt-periodical><pages>1389-405</pages><volume>12</volume><number>11</number><keywords><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Dermatomycoses/*drug therapy/microbiology/pathology</keyword><keyword>Humans</keyword><keyword>Onychomycosis/*drug therapy/microbiology/pathology</keyword><keyword>Subcutaneous Tissue/microbiology/pathology</keyword></keywords><dates><year>2014</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1744-8336 (Electronic)&#xD;1478-7210 (Linking)</isbn><accession-num>25241767</accession-num><urls><related-urls><url>;[478]. Skin biopsy should be taken from the center of the lesion and reach the subcutaneous fat in order to visualize hyphae invading blood vessels of the dermis and subcutaneous tissues ADDIN EN.CITE <EndNote><Cite><Author>van Burik</Author><Year>1998</Year><RecNum>790</RecNum><DisplayText>[9]</DisplayText><record><rec-number>790</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454359780">790</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>van Burik, J. A.</author><author>Colven, R.</author><author>Spach, D. H.</author></authors></contributors><auth-address>Department of Medicine, Division of Allergy and Infectious Diseases, Seattle, Washington, USA. jvanburi@</auth-address><titles><title>Cutaneous aspergillosis</title><secondary-title>J Clin Microbiol</secondary-title></titles><periodical><full-title>Journal of Clinical Microbiology</full-title><abbr-1>J. Clin. Microbiol.</abbr-1><abbr-2>J Clin Microbiol</abbr-2></periodical><pages>3115-21</pages><volume>36</volume><number>11</number><keywords><keyword>AIDS-Related Opportunistic Infections/diagnosis/etiology/therapy</keyword><keyword>Aspergillosis/diagnosis/*etiology/therapy</keyword><keyword>Aspergillus/isolation &amp; purification</keyword><keyword>Bone Marrow Transplantation/adverse effects</keyword><keyword>Burns/complications</keyword><keyword>Dermatomycoses/diagnosis/*etiology/therapy</keyword><keyword>Humans</keyword><keyword>Infant, Newborn</keyword><keyword>Neoplasms/complications</keyword><keyword>Organ Transplantation/adverse effects</keyword></keywords><dates><year>1998</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>0095-1137 (Print)&#xD;0095-1137 (Linking)</isbn><accession-num>9774549</accession-num><urls><related-urls><url>;[9]. What are the treatment recommendations for Aspergillus peritonitis?Recommendation57.We recommend prompt peritoneal dialysis catheter removal accompanied by systemic antifungal therapy with voriconazole (Strong Recommendation; Weak Quality Evidence). Evidence summaryAspergillus peritonitis may occur as a complication of chronic ambulatory peritoneal dialysis (PD) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYW5uaW5pPC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48

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ADDIN EN.CITE.DATA [480]. The diagnosis can be suggested by detection of (1→3)-β-D-glucan and GM in the peritoneal fluid, or confirmed by culture of peritoneal fluid ADDIN EN.CITE <EndNote><Cite><Author>Ates</Author><Year>2013</Year><RecNum>944</RecNum><DisplayText>[481]</DisplayText><record><rec-number>944</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454450682">944</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ates, O.</author><author>Metan, G.</author><author>Dundar, T.</author><author>Kiziltepe, M.</author><author>Kocyigit, I.</author><author>Unal, A.</author><author>Sipahioglu, M.</author><author>Oymak, O.</author><author>Tokgoz, B.</author></authors></contributors><titles><title>Diagnosis of Aspergillus niger peritonitis in a peritoneal dialysis patient by peritoneal galactomannan and beta-D-glucan detection</title><secondary-title>Perit Dial Int</secondary-title></titles><periodical><full-title>Peritoneal Dialysis International</full-title><abbr-1>Perit. Dial. Int.</abbr-1><abbr-2>Perit Dial Int</abbr-2></periodical><pages>216-8</pages><volume>33</volume><number>2</number><keywords><keyword>Adult</keyword><keyword>Aspergillosis/*diagnosis/etiology/metabolism</keyword><keyword>*Aspergillus niger</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Kidney Failure, Chronic/complications/therapy</keyword><keyword>Mannans/*metabolism</keyword><keyword>*Peritoneal Dialysis</keyword><keyword>Peritonitis/*diagnosis/metabolism/microbiology</keyword><keyword>beta-Glucans/*metabolism</keyword></keywords><dates><year>2013</year><pub-dates><date>Mar-Apr</date></pub-dates></dates><isbn>1718-4304 (Electronic)&#xD;0896-8608 (Linking)</isbn><accession-num>23478377</accession-num><urls><related-urls><url>;[481]. In rare cases peritoneal biopsy is required although this is typically accomplished concurrently with PD catheter removal ADDIN EN.CITE <EndNote><Cite><Author>Indramohan</Author><Year>2013</Year><RecNum>945</RecNum><DisplayText>[482]</DisplayText><record><rec-number>945</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454450717">945</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Indramohan, P.</author><author>Rohit, A.</author><author>Kanchanamala, M.</author><author>Mathew, M.</author><author>Abraham, G.</author></authors></contributors><titles><title>Culture-negative Aspergillus peritonitis diagnosed by peritoneal biopsy</title><secondary-title>Perit Dial Int</secondary-title></titles><periodical><full-title>Peritoneal Dialysis International</full-title><abbr-1>Perit. Dial. Int.</abbr-1><abbr-2>Perit Dial Int</abbr-2></periodical><pages>464-5</pages><volume>33</volume><number>4</number><keywords><keyword>Aspergillosis/*diagnosis/pathology</keyword><keyword>*Aspergillus niger/isolation &amp; purification</keyword><keyword>Biopsy</keyword><keyword>Fatal Outcome</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>*Peritoneal Dialysis, Continuous Ambulatory</keyword><keyword>Peritoneum/*microbiology/*pathology</keyword><keyword>Peritonitis/*diagnosis/*microbiology</keyword></keywords><dates><year>2013</year><pub-dates><date>Jul-Aug</date></pub-dates></dates><isbn>1718-4304 (Electronic)&#xD;0896-8608 (Linking)</isbn><accession-num>23843597</accession-num><urls><related-urls><url>;[482]. Removal of the dialysis catheter is essential in cases of fungal peritonitis and has been associated with improved survival. In cases where the catheter cannot be promptly removed, some practitioners use intraperitoneal amphotericin B in conjunction with voriconazole, but it should be recognized that intraperitoneal AmB administration may cause a chemical peritonitis and is not recommended by this panel ADDIN EN.CITE <EndNote><Cite><Author>Matuszkiewicz-Rowinska</Author><Year>2009</Year><RecNum>946</RecNum><DisplayText>[483]</DisplayText><record><rec-number>946</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454450777">946</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Matuszkiewicz-Rowinska, J.</author></authors></contributors><auth-address>Department of Nephrology, Dialysis and Internal Diseases, The Medical University of Warsaw, Warsaw, Poland. jotmatrow@o2.pl</auth-address><titles><title>Update on fungal peritonitis and its treatment</title><secondary-title>Perit Dial Int</secondary-title></titles><periodical><full-title>Peritoneal Dialysis International</full-title><abbr-1>Perit. Dial. Int.</abbr-1><abbr-2>Perit Dial Int</abbr-2></periodical><pages>S161-5</pages><volume>29 Suppl 2</volume><keywords><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Candida/isolation &amp; purification</keyword><keyword>*Candidiasis/epidemiology/etiology/therapy</keyword><keyword>Catheters, Indwelling/*adverse effects/microbiology</keyword><keyword>Device Removal/*methods</keyword><keyword>Humans</keyword><keyword>Incidence</keyword><keyword>Kidney Failure, Chronic/therapy</keyword><keyword>Peritoneal Dialysis, Continuous Ambulatory/*adverse effects/instrumentation</keyword><keyword>*Peritonitis/epidemiology/etiology/therapy</keyword><keyword>*Practice Guidelines as Topic</keyword><keyword>Prognosis</keyword><keyword>Risk Factors</keyword></keywords><dates><year>2009</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>0896-8608 (Print)&#xD;0896-8608 (Linking)</isbn><accession-num>19270208</accession-num><urls><related-urls><url>;[483]. 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ADDIN EN.CITE.DATA [484, 485]. Systemic therapy with voriconazole for 6-8 weeks is thus recommended based upon successful reports and adequate peritoneal concentrations in conjunction with catheter removal PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QZW5nPC9BdXRob3I+PFllYXI+MjAwNTwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [486, 487]. Posaconazole and the echinocandins have been successfully used in fungal peritonitis from other causes and may have utility as salvage therapy in Aspergillus peritonitis ADDIN EN.CITE <EndNote><Cite><Author>Li</Author><Year>2010</Year><RecNum>951</RecNum><DisplayText>[488]</DisplayText><record><rec-number>951</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454451002">951</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Li, P. K.</author><author>Szeto, C. C.</author><author>Piraino, B.</author><author>Bernardini, J.</author><author>Figueiredo, A. E.</author><author>Gupta, A.</author><author>Johnson, D. W.</author><author>Kuijper, E. J.</author><author>Lye, W. C.</author><author>Salzer, W.</author><author>Schaefer, F.</author><author>Struijk, D. G.</author><author>International Society for Peritoneal, Dialysis</author></authors></contributors><auth-address>Department of Medicine and Therapeutics, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong, Hong Kong. philipli@cuhk.edu.hk</auth-address><titles><title>Peritoneal dialysis-related infections recommendations: 2010 update</title><secondary-title>Perit Dial Int</secondary-title></titles><periodical><full-title>Peritoneal Dialysis International</full-title><abbr-1>Perit. Dial. Int.</abbr-1><abbr-2>Perit Dial Int</abbr-2></periodical><pages>393-423</pages><volume>30</volume><number>4</number><keywords><keyword>Catheters, Indwelling/microbiology</keyword><keyword>Humans</keyword><keyword>Peritoneal Dialysis/*adverse effects/instrumentation</keyword><keyword>Peritonitis/diagnosis/drug therapy/*etiology/microbiology</keyword><keyword>Prosthesis-Related Infections/diagnosis/drug therapy/*etiology</keyword></keywords><dates><year>2010</year><pub-dates><date>Jul-Aug</date></pub-dates></dates><isbn>1718-4304 (Electronic)&#xD;0896-8608 (Linking)</isbn><accession-num>20628102</accession-num><urls><related-urls><url>;[488]. Following treatment, a minority of patients may successfully return to peritoneal dialysis. What are the treatment recommendations for esophageal, gastrointestinal, and hepatic aspergillosis?Recommendations58.We suggest voriconazole and surgical consultation in attempts to prevent complications of hemorrhage, perforation, obstruction or infarction (Weak Recommendation; Low Quality Evidence). 59.We suggest antifungal therapy with voriconazole or a lipid formulation of AmB as initial therapy for hepatic aspergillosis. For extrahepatic or perihepatic biliary obstruction, or localized lesions that are refractory to medical therapy, surgical intervention should be considered (Weak Recommendation; Low Quality Evidence). Evidence summaryAspergillosis of the esophagus and gastrointestinal tract is relatively common in advanced cases of disseminated IA ADDIN EN.CITE <EndNote><Cite><Author>Young</Author><Year>1970</Year><RecNum>314</RecNum><DisplayText>[489]</DisplayText><record><rec-number>314</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1416245835">314</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Young, R. C.</author><author>Bennett, J. E.</author><author>Vogel, C. L.</author><author>Carbone, P. P.</author><author>DeVita, V. T.</author></authors></contributors><titles><title>Aspergillosis. The spectrum of the disease in 98 patients</title><secondary-title>Medicine (Baltimore)</secondary-title><alt-title>Medicine</alt-title></titles><periodical><full-title>Medicine (Baltimore)</full-title><abbr-1>Medicine (Baltimore)</abbr-1><abbr-2>Medicine (Baltimore)</abbr-2></periodical><alt-periodical><full-title>Medicine</full-title><abbr-1>Medicine</abbr-1><abbr-2>Medicine</abbr-2></alt-periodical><pages>147-73</pages><volume>49</volume><number>2</number><keywords><keyword>Anemia, Aplastic/complications</keyword><keyword>*Aspergillosis/complications/diagnosis/pathology</keyword><keyword>Autopsy</keyword><keyword>Bronchiectasis/complications</keyword><keyword>Cardiovascular Diseases/complications</keyword><keyword>Humans</keyword><keyword>Leukemia/complications</keyword><keyword>Lymphoma/complications</keyword><keyword>Neoplasms/complications</keyword><keyword>Respiratory Tract Infections</keyword></keywords><dates><year>1970</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0025-7974 (Print)&#xD;0025-7974 (Linking)</isbn><accession-num>4913991</accession-num><urls><related-urls><url>;[489]. In fact, in autopsy studies, esophageal and gastrointestinal tract involvement is the third most common site of infection ADDIN EN.CITE <EndNote><Cite><Author>Young</Author><Year>1970</Year><RecNum>314</RecNum><DisplayText>[489]</DisplayText><record><rec-number>314</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1416245835">314</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Young, R. C.</author><author>Bennett, J. E.</author><author>Vogel, C. L.</author><author>Carbone, P. P.</author><author>DeVita, V. T.</author></authors></contributors><titles><title>Aspergillosis. The spectrum of the disease in 98 patients</title><secondary-title>Medicine (Baltimore)</secondary-title><alt-title>Medicine</alt-title></titles><periodical><full-title>Medicine (Baltimore)</full-title><abbr-1>Medicine (Baltimore)</abbr-1><abbr-2>Medicine (Baltimore)</abbr-2></periodical><alt-periodical><full-title>Medicine</full-title><abbr-1>Medicine</abbr-1><abbr-2>Medicine</abbr-2></alt-periodical><pages>147-73</pages><volume>49</volume><number>2</number><keywords><keyword>Anemia, Aplastic/complications</keyword><keyword>*Aspergillosis/complications/diagnosis/pathology</keyword><keyword>Autopsy</keyword><keyword>Bronchiectasis/complications</keyword><keyword>Cardiovascular Diseases/complications</keyword><keyword>Humans</keyword><keyword>Leukemia/complications</keyword><keyword>Lymphoma/complications</keyword><keyword>Neoplasms/complications</keyword><keyword>Respiratory Tract Infections</keyword></keywords><dates><year>1970</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>0025-7974 (Print)&#xD;0025-7974 (Linking)</isbn><accession-num>4913991</accession-num><urls><related-urls><url>;[489]. 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ADDIN EN.CITE.DATA [490] although this has not been definitively demonstrated. The few well-documented cases have been associated with high morbidity and mortality and the diagnosis is infrequently made antemortem PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5FZ2dpbWFubjwvQXV0aG9yPjxZZWFyPjIwMDY8L1llYXI+

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ADDIN EN.CITE.DATA [493]. Cholangitis secondary to Aspergillus spp. is exceedingly uncommon, but has been described following biliary surgery ADDIN EN.CITE <EndNote><Cite><Author>Erdman</Author><Year>2002</Year><RecNum>321</RecNum><DisplayText>[494]</DisplayText><record><rec-number>321</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1416252023">321</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Erdman, S. H.</author><author>Barber, B. J.</author><author>Barton, L. L.</author></authors></contributors><auth-address>Sections of Gastroenterology &amp; Nutrition and Infectious Diseases, the Department of Pediatrics, Steele Memorial Children&apos;s Research Center, University of Arizona, Tucson, AZ, USA.</auth-address><titles><title>Aspergillus cholangitis: A late complication after Kasai portoenterostomy</title><secondary-title>J Pediatr Surg</secondary-title><alt-title>Journal of pediatric surgery</alt-title></titles><periodical><full-title>Journal of Pediatric Surgery</full-title><abbr-1>J. Pediatr. Surg.</abbr-1><abbr-2>J Pediatr Surg</abbr-2></periodical><alt-periodical><full-title>Journal of Pediatric Surgery</full-title><abbr-1>J. Pediatr. Surg.</abbr-1><abbr-2>J Pediatr Surg</abbr-2></alt-periodical><pages>923-5</pages><volume>37</volume><number>6</number><keywords><keyword>Adult</keyword><keyword>Aspergillosis/diagnosis/drug therapy/*etiology</keyword><keyword>Cholangitis/diagnosis/drug therapy/*etiology</keyword><keyword>Enterostomy/*adverse effects</keyword><keyword>Fatal Outcome</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hyperbilirubinemia/surgery</keyword><keyword>Infant</keyword></keywords><dates><year>2002</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1531-5037 (Electronic)&#xD;0022-3468 (Linking)</isbn><accession-num>12037766</accession-num><urls><related-urls><url>;[494]. Reports of therapeutic interventions are limited. Medical therapy for hepatic abscesses may be effective and preclude the need for surgical resection.What are the treatment recommendations for renal aspergillosis?Recommendation60.We suggest a combined approach of medical and urologic management for renal aspergillosis. Obstruction of one or both ureters should be managed with decompression if possible and local instillation of AmB deoxycholate. Parenchymal disease is best treated with voriconazole (Weak Recommendation; Low Quality Evidence).Evidence summaryRenal aspergillosis may develop as single or multiple parenchymal abscesses, usually as a result of hematogenous dissemination, or may present as a fungal ball in the pelvis of the kidney PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MaXNzb248L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [495, 496]. This form of aspergillosis may cause hematuria, ureteropelvic obstruction from a fungal ball, perinephric abscess with extension into surrounding tissues, or passing of fungal elements into the urine.Reports of management are limited to individual cases. Medical management alone may be successful if abscesses are relatively small. Management of larger abscesses may require surgical drainage. Microwave ablation has been successfully used as an adjunct to antifungal therapy in a single patient deemed a poor surgical candidate ADDIN EN.CITE <EndNote><Cite><Author>Waller</Author><Year>2014</Year><RecNum>322</RecNum><DisplayText>[497]</DisplayText><record><rec-number>322</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1416264179">322</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Waller, S.</author><author>Raglow, Z.</author><author>Lemons, S.</author><author>Johnson, P.</author><author>Eid, A.</author><author>Schmitt, T.</author><author>Smothers, J.</author><author>O&apos;Neil, M.</author><author>Gilroy, R.</author></authors></contributors><auth-address>Division of Infectious Diseases, The University of Kansas Medical Center, Kansas City, Kansas, USA.</auth-address><titles><title>Microwave ablation of a large renal aspergilloma</title><secondary-title>Transpl Infect Dis</secondary-title><alt-title>Transplant infectious disease : an official journal of the Transplantation Society</alt-title></titles><periodical><full-title>Transplant Infectious Disease</full-title><abbr-1>Transpl. Infect. Dis.</abbr-1><abbr-2>Transpl Infect Dis</abbr-2></periodical><pages>496-500</pages><volume>16</volume><number>3</number><dates><year>2014</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1399-3062 (Electronic)&#xD;1398-2273 (Linking)</isbn><accession-num>24862024</accession-num><urls><related-urls><url>;[497]. Nephrectomy should be performed only as a last option. Voriconazole, posaconazole, itraconazole, AmB formulations, and the echinocandins all exhibit poor urinary concentrations ADDIN EN.CITE <EndNote><Cite><Author>Kauffman</Author><Year>2014</Year><RecNum>323</RecNum><DisplayText>[498]</DisplayText><record><rec-number>323</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1416265091">323</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kauffman, C. A.</author></authors></contributors><auth-address>Division of Infectious Diseases, Veterans Affairs Ann Arbor Healthcare System, University of Michigan Medical School, 2215 Fuller Road, Ann Arbor, MI 48105, USA. Electronic address: ckauff@umich.edu.</auth-address><titles><title>Diagnosis and management of fungal urinary tract infection</title><secondary-title>Infect Dis Clin North Am</secondary-title><alt-title>Infectious disease clinics of North America</alt-title></titles><periodical><full-title>Infectious Disease Clinics of North America</full-title><abbr-1>Infect. Dis. Clin. North Am.</abbr-1><abbr-2>Infect Dis Clin North Am</abbr-2></periodical><alt-periodical><full-title>Infectious Disease Clinics of North America</full-title><abbr-1>Infect. Dis. Clin. North Am.</abbr-1><abbr-2>Infect Dis Clin North Am</abbr-2></alt-periodical><pages>61-74</pages><volume>28</volume><number>1</number><keywords><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Candidiasis/*diagnosis/*drug therapy</keyword><keyword>Humans</keyword><keyword>Practice Guidelines as Topic</keyword><keyword>Risk Factors</keyword><keyword>Urinary Tract Infections/*diagnosis/drug therapy/*microbiology</keyword></keywords><dates><year>2014</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1557-9824 (Electronic)&#xD;0891-5520 (Linking)</isbn><accession-num>24484575</accession-num><urls><related-urls><url>;[498]. Irrigation via a nephrostomy tube with AmB deoxycholate allows high local concentrations and given by this route is not absorbed and is not nephrotoxic. It thus may be useful in aspergillosis of the renal pelvis but has no role in the treatment of parenchymal disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJ0aW5lei1QYWphcmVzPC9BdXRob3I+PFllYXI+MjAx

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ADDIN EN.CITE.DATA [500, 501]. IA can involve the external auditory canal, middle ear, mastoid or petrous portion of the temporal bone. When invasion begins in the external auditory canal, infection has been called malignant otitis externa. Tissue invasive Aspergillus otitis should be treated with prolonged systemic antifungals ADDIN EN.CITE <EndNote><Cite><Author>Karkas</Author><Year>2013</Year><RecNum>336</RecNum><DisplayText>[453]</DisplayText><record><rec-number>336</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1416522530">336</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Karkas, A.</author><author>Rtail, R.</author><author>Reyt, E.</author><author>Timi, N.</author><author>Righini, C. A.</author></authors></contributors><auth-address>Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital of Grenoble, PO Box 217, 38043, Grenoble Cedex 9, France. akarkas@chu-grenoble.fr</auth-address><titles><title>Sphenoid sinus fungus ball</title><secondary-title>Eur Arch Otorhinolaryngol</secondary-title><alt-title>European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies</alt-title></titles><periodical><full-title>European Archives of Oto-Rhino-Laryngology</full-title><abbr-1>Eur. Arch. Otorhinolaryngol.</abbr-1><abbr-2>Eur Arch Otorhinolaryngol</abbr-2></periodical><pages>893-8</pages><volume>270</volume><number>3</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>Aspergillosis/*diagnosis/surgery</keyword><keyword>Endoscopy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Magnetic Resonance Imaging</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Retrospective Studies</keyword><keyword>Sphenoid Sinusitis/*diagnosis/surgery</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2013</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1434-4726 (Electronic)&#xD;0937-4477 (Linking)</isbn><accession-num>22850907</accession-num><urls><related-urls><url>;[453], preferably with voriconazole, usually preceded by surgical debridement PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CaGF0dDwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [502-505]. Colonization of the middle ear and mastoid by Candida, Aspergillus, or other moulds can occur in patients with chronic otitis media in the presence of a perforated tympanic membrane, usually following multiple surgical procedures and many courses of antibacterial agents. In the absence of evidence of tissue invasion, we do not recommend that colonization should be treated PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WZW5uZXdhbGQ8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFy

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ADDIN EN.CITE.DATA [506].What are the treatment recommendations for Aspergillus keratitis?Recommendation63.We recommend that clinicians treat Aspergillus keratitis with topical natamycin 5% ophthalmic suspension or topical voriconazole (Strong Recommendation; Moderate Quality Evidence).Evidence summaryClinicians should treat Aspergillus keratitis with topical natamycin 5% ophthalmic suspension. In case series and randomized clinical trials of fungal keratitis, topical voriconazole 1% was inferior to natamycin but Fusarium keratitis appeared to account for most of the difference PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QcmFqbmE8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [507-510]. Voriconazole for infusion, reconstituted with water to 1%, is a reasonable alternative for Aspergillus keratitis. Diagnosis should be confirmed by smear and culture of corneal scrapings ADDIN EN.CITE <EndNote><Cite><Author>Thomas</Author><Year>2013</Year><RecNum>963</RecNum><DisplayText>[511]</DisplayText><record><rec-number>963</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454451892">963</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Thomas, P. A.</author><author>Kaliamurthy, J.</author></authors></contributors><auth-address>Department of Ocular Microbiology, Institute of Ophthalmology, Joseph Eye Hospital, Tiruchirapalli, India. philipthomas@</auth-address><titles><title>Mycotic keratitis: epidemiology, diagnosis and management</title><secondary-title>Clin Microbiol Infect</secondary-title></titles><periodical><full-title>Clinical Microbiology and Infection</full-title><abbr-1>Clin. Microbiol. Infect.</abbr-1><abbr-2>Clin Microbiol Infect</abbr-2><abbr-3>Clinical Microbiology &amp; Infection</abbr-3></periodical><pages>210-20</pages><volume>19</volume><number>3</number><keywords><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Clinical Laboratory Techniques/methods</keyword><keyword>Debridement</keyword><keyword>Fungi/classification/isolation &amp; purification</keyword><keyword>Humans</keyword><keyword>Immunocompromised Host</keyword><keyword>Keratitis/*diagnosis/*epidemiology/microbiology/therapy</keyword><keyword>Mycoses/*diagnosis/*epidemiology/microbiology/therapy</keyword><keyword>Wounds and Injuries/complications</keyword></keywords><dates><year>2013</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1469-0691 (Electronic)&#xD;1198-743X (Linking)</isbn><accession-num>23398543</accession-num><urls><related-urls><url>;[511]. Confocal microscopy and anterior segment coherence tomography are useful to monitor therapeutic response ADDIN EN.CITE <EndNote><Cite><Author>Thomas</Author><Year>2013</Year><RecNum>963</RecNum><DisplayText>[511]</DisplayText><record><rec-number>963</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454451892">963</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Thomas, P. A.</author><author>Kaliamurthy, J.</author></authors></contributors><auth-address>Department of Ocular Microbiology, Institute of Ophthalmology, Joseph Eye Hospital, Tiruchirapalli, India. philipthomas@</auth-address><titles><title>Mycotic keratitis: epidemiology, diagnosis and management</title><secondary-title>Clin Microbiol Infect</secondary-title></titles><periodical><full-title>Clinical Microbiology and Infection</full-title><abbr-1>Clin. Microbiol. Infect.</abbr-1><abbr-2>Clin Microbiol Infect</abbr-2><abbr-3>Clinical Microbiology &amp; Infection</abbr-3></periodical><pages>210-20</pages><volume>19</volume><number>3</number><keywords><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Clinical Laboratory Techniques/methods</keyword><keyword>Debridement</keyword><keyword>Fungi/classification/isolation &amp; purification</keyword><keyword>Humans</keyword><keyword>Immunocompromised Host</keyword><keyword>Keratitis/*diagnosis/*epidemiology/microbiology/therapy</keyword><keyword>Mycoses/*diagnosis/*epidemiology/microbiology/therapy</keyword><keyword>Wounds and Injuries/complications</keyword></keywords><dates><year>2013</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1469-0691 (Electronic)&#xD;1198-743X (Linking)</isbn><accession-num>23398543</accession-num><urls><related-urls><url>;[511]. Ophthalmologists should consider penetrating keratoplasty for patients who do not respond to topical therapy, though patients with lesions extending to the corneal limbus, with corneal perforation or hypopyon are at high risk of recurrence PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaGk8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxSZWNO

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ADDIN EN.CITE.DATA [512]. How should Aspergillus bronchitis be diagnosed and treated in the non-transplant population?Recommendations64.We suggest the diagnosis of aspergillus bronchitis in non-transplant patients be confirmed by detection of Aspergillus spp. in respiratory secretions, usually sputum, with both PCR and GM on respiratory samples being much more sensitive than culture (Weak Recommendation; Low Quality Evidence).65.??? We suggest treatment with oral itraconazole or voriconazole with therapeutic drug monitoring (Weak Recommendation; Low Quality Evidence).Evidence summaryAspergillus is a cause of acute or chronic bronchitis usually seen as a complication of CF or bronchiectasis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LYXJuYWs8L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [83, 513, 514]. Its clinical features are not distinctive in CF, but include a more rapid decline in FEV1 than those without ABPA or Aspergillus sensitization. It affects up to ~30% of adults with CF ADDIN EN.CITE <EndNote><Cite><Author>Armstead</Author><Year>2014</Year><RecNum>98</RecNum><DisplayText>[515]</DisplayText><record><rec-number>98</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1406160424">98</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Armstead, J.</author><author>Morris, J.</author><author>Denning, D. W.</author></authors></contributors><auth-address>National Aspergillosis Centre, University Hospital South Manchester, The University of Manchester and Manchester Academic Health Science Centre, Manchester, United Kingdom.</auth-address><titles><title>Multi-country estimate of different manifestations of aspergillosis in cystic fibrosis</title><secondary-title>PLoS One</secondary-title><alt-title>PloS one</alt-title></titles><periodical><full-title>PloS One</full-title><abbr-1>PLoS One</abbr-1><abbr-2>PLoS One</abbr-2></periodical><alt-periodical><full-title>PloS One</full-title><abbr-1>PLoS One</abbr-1><abbr-2>PLoS One</abbr-2></alt-periodical><pages>e98502</pages><volume>9</volume><number>6</number><dates><year>2014</year></dates><isbn>1932-6203 (Electronic)&#xD;1932-6203 (Linking)</isbn><accession-num>24914809</accession-num><urls><related-urls><url>;[515]. Patients present with recurrent, frequently relapsing acute bronchitis with thick sputum plugging and shortness of breath. Occasional patients develop mucoid impaction, or so-called “plastic bronchitis”, requiring urgent bronchial toilet. Identification of Aspergillus in airway secretions with culture, PCR or GM is essential for the diagnosis, and elevated Aspergillus IgG serology is supportive of the diagnosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LYXJuYWs8L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [514, 516], but this has not been systematically studied. Itraconazole or voriconazole are first line agents. Patients who fail one azole agent, may respond to a different azole. Relapse after improvement during antifungal therapy is common; long-term suppressive therapy may be necessary for symptom control. Triazole antifungal resistance has been documented, and so susceptibility testing is valuable. The role of inhaled antifungal therapy is uncertain.V. What are the recommended prophylactic regimens: who should receive them and how should breakthrough infection be managed?PROPHYLAXIS OF IAIn what patients should antifungal prophylaxis against aspergillosis be used? Recommendation66.We recommend prophylaxis with posaconazole (Strong Recommendation; High Quality Evidence), voriconazole (Strong Recommendation; Moderate Quality Evidence), and/or micafungin (Weak Recommendation; Low Quality Evidence) during prolonged neutropenia for those who are at high risk for IA (Strong Recommendation; High Quality Evidence). Prophylaxis with caspofungin is also probably effective (Weak Recommendation; Low Quality Evidence). Prophylaxis with itraconazole is effective, but therapy may be limited by absorption and tolerability (Strong Recommendation; Moderate Quality Evidence). Triazoles should not be co-administered with other agents known to have potentially toxic levels with concurrent triazole coadministration (such as vinca alkaloids, and others) (Strong Recommendation; Moderate Quality Evidence).Evidence summaryHematologic disorders with poorly functioning neutrophils (e.g., aplastic anemia and variants thereof, MDS), acute leukemia with repeated and/or prolonged neutropenia, ADDIN EN.CITE <EndNote><Cite><Author>Wald</Author><Year>1997</Year><RecNum>964</RecNum><DisplayText>[517]</DisplayText><record><rec-number>964</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454451934">964</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Wald, A.</author><author>Leisenring, W.</author><author>van Burik, J. A.</author><author>Bowden, R. A.</author></authors></contributors><auth-address>Department of Medicine, University of Washington, Seattle 98122, USA.</auth-address><titles><title>Epidemiology of Aspergillus infections in a large cohort of patients undergoing bone marrow transplantation</title><secondary-title>J Infect Dis</secondary-title></titles><periodical><full-title>Journal of Infectious Diseases</full-title><abbr-1>J. Infect. Dis.</abbr-1><abbr-2>J Infect Dis</abbr-2></periodical><pages>1459-66</pages><volume>175</volume><number>6</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aspergillosis/diagnosis/*epidemiology</keyword><keyword>Aspergillus/isolation &amp; purification</keyword><keyword>*Bone Marrow Transplantation</keyword><keyword>Cohort Studies</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Incidence</keyword><keyword>Male</keyword><keyword>Neutropenia</keyword><keyword>Opportunistic Infections/diagnosis/*epidemiology</keyword><keyword>Organ Specificity</keyword><keyword>Proportional Hazards Models</keyword><keyword>Retrospective Studies</keyword><keyword>Risk Factors</keyword><keyword>Seasons</keyword><keyword>Transplantation, Autologous</keyword><keyword>Transplantation, Homologous</keyword></keywords><dates><year>1997</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0022-1899 (Print)&#xD;0022-1899 (Linking)</isbn><accession-num>9180187</accession-num><urls><related-urls><url>;[517], or a history of IA prior to transplantation PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GdWt1ZGE8L0F1dGhvcj48WWVhcj4yMDA0PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [294]. This study demonstrated higher survival for patients in the posaconazole arm, although there was greater toxicity among recipients of posaconazole, compared with the fluconazole/itraconazole arm. With the approval of an extended release tablet form of posaconazole, as well as an IV form, dosing will be different compared to the randomized prophylaxis trials which used a solution formulation and needs further evaluation in HSCT patients.A previous trial compared voriconazole or fluconazole prophylaxis in allogeneic HSCT recipients, both arms were monitored with GM measurements PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaW5nYXJkPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48

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ADDIN EN.CITE.DATA [519]. In another trial, voriconazole was used as prophylaxis for leukemia patients with about 3 weeks of neutropenia during a construction risk period, less aspergillosis was noted among patients receiving prophylaxis (P=0.04) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFicm9sPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48

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ADDIN EN.CITE.DATA [521]. Voriconazole requires careful monitoring in children ADDIN EN.CITE <EndNote><Cite><Author>Peksa</Author><Year>2015</Year><RecNum>967</RecNum><DisplayText>[522]</DisplayText><record><rec-number>967</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454452069">967</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Peksa, G. D.</author><author>Schultz, K.</author><author>Fung, H. C.</author></authors></contributors><auth-address>Department of Pharmacy, Rush University Medical Center, Chicago, IL, USA gary_d_peksa@rush.edu.&#xD;Department of Pharmacy, Rush University Medical Center, Chicago, IL, USA.&#xD;Division of Hematology, Oncology and Stem Cell Transplant, Rush University Medical Center, Chicago, IL, USA.</auth-address><titles><title>Dosing algorithm for concomitant administration of sirolimus, tacrolimus, and an azole after allogeneic hematopoietic stem cell transplantation</title><secondary-title>J Oncol Pharm Pract</secondary-title></titles><periodical><full-title>Journal of Oncology Pharmacy Practice</full-title><abbr-1>J. Oncol. Pharm. Pract.</abbr-1><abbr-2>J Oncol Pharm Pract</abbr-2></periodical><pages>409-15</pages><volume>21</volume><number>6</number><keywords><keyword>Sirolimus</keyword><keyword>azoles</keyword><keyword>dosing scheme</keyword><keyword>hematopoietic stem cell transplantation</keyword><keyword>interaction</keyword><keyword>tacrolimus</keyword></keywords><dates><year>2015</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>1477-092X (Electronic)&#xD;1078-1552 (Linking)</isbn><accession-num>24938293</accession-num><urls><related-urls><url>;[522]. Patients receiving voriconazole prophylaxis remain at risk for both Aspergillus and non-Aspergillus fungal pathogens that are intrinsically resistant to this agent PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaXdlazwvQXV0aG9yPjxZZWFyPjIwMDQ8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [523, 524]. A 2004 large, randomized prophylaxis trial comparing micafungin or fluconazole prophylaxis found the composite endpoint of treatment success was significantly better among those receiving micafungin prophylaxis (p=0.03), as there was less empirical AmB during neutropenia (15.1% vs 21.4%), fewer breakthrough fungal infections (1.6 vs. 2.4%), and less yeast colonization among those receiving micafungin prophylaxis (p=0.03) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj52YW4gQnVyaWs8L0F1dGhvcj48WWVhcj4yMDA0PC9ZZWFy

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ADDIN EN.CITE.DATA [525]. In clinical practice, the requirement for daily IV therapy with echinocandins may lead to a change to oral azole therapy at a time not studied in clinical trials but these agents may be useful for prophylaxis when drugs which are contraindicated with triazoles (such as cyclophosphamide or vincristine) are required.Caspofungin has been studied in smaller settings. The efficacy and safety of caspofungin was similar to other prophylactic regimens, in the setting of a low incidence of invasive fungal infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYXR0YW5lbzwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+

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ADDIN EN.CITE.DATA [526-529]. Itraconazole may be effective, but the conclusions of several prospective trials regarding efficacy are limited, because study designs did not include patients at significant risk for aspergillosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3c8L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxSZWNO

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ADDIN EN.CITE.DATA [534]. Since there was an increase in transplant-related mortality when itraconazole was used together with cyclophosphamide during the conditioning regimen for HSCT, azole dosing is now delayed until after the stem cell product infusion PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJyPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj

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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJyPC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [535]. Earlier studies of antifungal prophylaxis in hematologic malignancies are summarized in several large meta-analyses PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYXJkYWthczwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+

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ADDIN EN.CITE.DATA [530, 536, 537]. Among the studies that investigated parenterally administered AmB deoxycholate or liposomal formulations of AmB for prophylaxis, most have been historically controlled, and some have suggested a reduction in IA. Several prospective, randomized trials using polyene therapy have demonstrated a reduction in the number of invasive fungal infections, but none have demonstrated a significant reduction of IA in a prospective, randomized study PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb3VzZXk8L0F1dGhvcj48WWVhcj4xOTkxPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [179]. What are the recommended prophylactic regimens for patients with GVHD? Recommendations67.We recommend prophylaxis with posaconazole for allogeneic HSCT recipients with GVHD who are at high risk for IA (Strong Recommendation; High Quality Evidence). Prophylaxis with other mould-active azoles is also effective. Voriconazole is commonly used for prophylaxis against IA in high risk patients but did not show improved survival in clinical trials (Strong Recommendation; Moderate Quality Evidence). Prophylaxis with itraconazole is limited by tolerability and absorption (Strong Recommendation; High Quality Evidence). 68.We recommend continuation of antifungal prophylaxis throughout the duration of immunosuppression in patients with chronic immunosuppression associated with GVHD (corticosteroid equivalent of >1 mg/kg/day of prednisone for >2 weeks and/or the use of other anti-GVHD therapies, such as lymphocyte depleting agents, or TNF-α inhibition, for refractory GVHD) (Strong Recommendation; High Quality Evidence).Evidence summaryA randomized clinical trial of posaconazole prophylaxis during GVHD in HSCT recipients found a significant reduction in proven and probable invasive fungal infections and similar toxicity in posaconazole recipients, compared with those receiving fluconazole, which has no mould activity PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5VbGxtYW5uPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48

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ADDIN EN.CITE.DATA [256]. Since this time posaconazole tablets have become available and have replaced the use of oral solution at many centers and may further improve serum posaconazole levels without clinically relevant hepatotoxicity ADDIN EN.CITE <EndNote><Cite><Author>Jung</Author><Year>2014</Year><RecNum>166</RecNum><DisplayText>[246]</DisplayText><record><rec-number>166</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412203587">166</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jung, D. S.</author><author>Tverdek, F. P.</author><author>Kontoyiannis, D. P.</author></authors></contributors><auth-address>Departments of Infectious Diseases, Infection Control, and Employee Health Division of Infectious Diseases, Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.&#xD;Pharmacy Clinical Programs, The University of Texas MD Anderson Cancer Center, Houston, TX.&#xD;Departments of Infectious Diseases, Infection Control, and Employee Health dkontoyi@.</auth-address><titles><title>Switching from Posaconazole Suspension to Tablets Increased Serum Levels in Leukemia Patients without Clinically Relevant Hepatotoxicity</title><secondary-title>Antimicrob Agents Chemother</secondary-title><alt-title>Antimicrobial agents and chemotherapy</alt-title></titles><periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob. Agents Chemother.</abbr-1><abbr-2>Antimicrob Agents Chemother</abbr-2><abbr-3>Antimicrobial Agents &amp; Chemotherapy</abbr-3></periodical><alt-periodical><full-title>Antimicrobial Agents and Chemotherapy</full-title><abbr-1>Antimicrob. Agents Chemother.</abbr-1><abbr-2>Antimicrob Agents Chemother</abbr-2><abbr-3>Antimicrobial Agents &amp; Chemotherapy</abbr-3></alt-periodical><dates><year>2014</year><pub-dates><date>Sep 8</date></pub-dates></dates><isbn>1098-6596 (Electronic)&#xD;0066-4804 (Linking)</isbn><accession-num>25199774</accession-num><urls><related-urls><url>;[246]. A 2010 large, randomized clinical trial of voriconazole prophylaxis following allogeneic transplant continued the antifungal prophylaxis to day 180 for higher risk patients such as those with GVHD PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaW5nYXJkPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48

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ADDIN EN.CITE.DATA [521]. Acute GVHD is a risk factor for hepatotoxicity attributable to voriconazole that requires careful monitoring in this setting PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbWlndWVzPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48

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ADDIN EN.CITE.DATA [523, 524].What are the recommendations for antifungal prophylaxis in lung transplant patients?Recommendations69.We recommend antifungal prophylaxis with either a systemic triazole such as voriconazole or itraconazole or an inhaled AmB product for 3 to 4 months after lung transplant (Strong Recommendation; Moderate Quality Evidence).70.Systemic voriconazole or itraconazole is suggested over inhaled AmB for lung transplant recipients with mould colonization pre- or post- lung transplantation, mould infections found in explanted lungs, fungal infections in the sinus, and single lung transplant recipients. (Weak Recommendation; Low Quality Evidence).71.We recommend reinitiating antifungal prophylaxis for lung transplant recipients receiving immunosuppression augmentation with either thymoglobulin, alemtuzumab, or high dose corticosteroids (Strong Recommendation; Moderate Quality Evidence).Evidence summaryAntifungal prophylaxis for lung transplant recipients is commonplace at many centers, but not employed universally ADDIN EN.CITE <EndNote><Cite><Author>Neoh</Author><Year>2011</Year><RecNum>987</RecNum><DisplayText>[544]</DisplayText><record><rec-number>987</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454454370">987</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Neoh, C. F.</author><author>Snell, G. I.</author><author>Kotsimbos, T.</author><author>Levvey, B.</author><author>Morrissey, C. O.</author><author>Slavin, M. A.</author><author>Stewart, K.</author><author>Kong, D. C.</author></authors></contributors><auth-address>Department of Pharmacy Practice, Center for Medicine Use and Safety, Monash University, Melbourne, Australia.</auth-address><titles><title>Antifungal prophylaxis in lung transplantation--a world-wide survey</title><secondary-title>Am J Transplant</secondary-title></titles><periodical><full-title>American Journal of Transplantation</full-title><abbr-1>Am. J. Transplant.</abbr-1><abbr-2>Am J Transplant</abbr-2></periodical><pages>361-6</pages><volume>11</volume><number>2</number><keywords><keyword>Adult</keyword><keyword>Antifungal Agents/*pharmacology</keyword><keyword>Data Collection</keyword><keyword>Europe</keyword><keyword>Humans</keyword><keyword>Lung Transplantation/adverse effects/*methods</keyword><keyword>Mycoses/etiology/*prevention &amp; control</keyword><keyword>Time Factors</keyword><keyword>United States</keyword></keywords><dates><year>2011</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1600-6143 (Electronic)&#xD;1600-6135 (Linking)</isbn><accession-num>21272239</accession-num><urls><related-urls><url>;[544]. Furthermore, the types of prophylaxis (inhaled or systemic), antifungal agents used, and duration of prophylaxis also vary PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2hhZW5tYW48L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy

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ADDIN EN.CITE.DATA [544, 545]. To date, there have been no prospective comparative trials evaluating the long-term benefit of antifungal prophylaxis among lung transplant recipients. Retrospective and observational studies with historical controls showed lower rates of invasive fungal infections among patients receiving antifungal prophylaxis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EcmV3PC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [546-549]. Given these data, the presence of damaged airways early after transplant (see TBA above), high levels of immunosuppression following lung transplant, and poor outcomes of invasive fungal infections, it is reasonable to consider antifungal prophylaxis in the early post-transplant period. Aerosolized AmB formulations have been shown to protect lung transplant recipients from pulmonary fungal infections PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EcmV3PC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj

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PgB=

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PgB=

ADDIN EN.CITE.DATA [546]. There is no evidence that one formulation of AmB is superior to others, but the AmB deoxycholate is associated with more side effects than other formulations including: cough, bronchospasm, taste disturbance, and nausea as well as difficulty in administering the drug PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EcmV3PC9BdXRob3I+PFllYXI+MjAwNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [178, 184, 185, 546, 550-552]. The longer tissue half-life of the lipid formulations of AmB also permits less frequent administration PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb25mb3J0ZTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+

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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb25mb3J0ZTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+

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ADDIN EN.CITE.DATA [185]. An advantage of inhaled AmB is the lack of systemic adverse effects and/or drug-drug interactions; a disadvantage is its inability to prevent extra-pulmonary fungal infections. Systemic voriconazole and itraconazole are also effective in preventing invasive fungal infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYWRlbmE8L0F1dGhvcj48WWVhcj4yMDA5PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [430, 548]. To date, there is no evidence that one agent is superior to the other. Azole prophylaxis is complicated by drug interactions with the calcineurin inhibitors, as well as liver toxicity. It should be noted that antifungal prophylaxis might only delay the onset of invasive fungal infection ADDIN EN.CITE <EndNote><Cite><Author>Hosseini-Moghaddam</Author><Year>2010</Year><RecNum>995</RecNum><DisplayText>[553]</DisplayText><record><rec-number>995</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454454814">995</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hosseini-Moghaddam, S. M.</author><author>Husain, S.</author></authors></contributors><auth-address>Multiorgan Transplant Infectious Diseases Division, University of Toronto, Toronto, Ontario, Canada.</auth-address><titles><title>Fungi and molds following lung transplantation</title><secondary-title>Semin Respir Crit Care Med</secondary-title></titles><periodical><full-title>Seminars in Respiratory and Critical Care Medicine</full-title><abbr-1>Semin. Respir. Crit. Care Med.</abbr-1><abbr-2>Semin Respir Crit Care Med</abbr-2><abbr-3>Seminars in Respiratory &amp; Critical Care Medicine</abbr-3></periodical><pages>222-33</pages><volume>31</volume><number>2</number><keywords><keyword>Antifungal Agents/administration &amp; dosage</keyword><keyword>Fungi/*isolation &amp; purification</keyword><keyword>Humans</keyword><keyword>Lung Diseases, Fungal/drug therapy/microbiology</keyword><keyword>Lung Transplantation/*adverse effects</keyword></keywords><dates><year>2010</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1098-9048 (Electronic)&#xD;1069-3424 (Linking)</isbn><accession-num>20354934</accession-num><urls><related-urls><url>;[553], since the allograft is exposed to the environment, and patients are maintained on relatively high doses of immunosuppression lifelong. ?In the absence of a head-to-head comparative trial of inhaled AmB vs. a systemic mould-active antifungal, we suggest that systemic voriconazole or itraconazole be considered for: 1) patients colonized with Aspergillus or other pathogenic moulds pre- or post- lung transplant PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IZWxtaTwvQXV0aG9yPjxZZWFyPjIwMDM8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [556]; 3) patients with evidence of fungal infections in the sinus; and 4) single lung transplant recipients ADDIN EN.CITE <EndNote><Cite><Author>Singh</Author><Year>2003</Year><RecNum>996</RecNum><DisplayText>[557]</DisplayText><record><rec-number>996</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1454454864">996</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Singh, N.</author><author>Husain, S.</author></authors></contributors><auth-address>Veterans Affairs Medical Center and University of Pittsburgh Medical Center, Thomas E Starzl Transplantation Institute, Pittsburgh, Pennsylvania 15240, USA. nis5+@pitt.edu</auth-address><titles><title>Aspergillus infections after lung transplantation: clinical differences in type of transplant and implications for management</title><secondary-title>J Heart Lung Transplant</secondary-title></titles><periodical><full-title>Journal of Heart and Lung Transplantation</full-title><abbr-1>J. Heart Lung Transplant.</abbr-1><abbr-2>J Heart Lung Transplant</abbr-2><abbr-3>Journal of Heart &amp; Lung Transplantation</abbr-3></periodical><pages>258-66</pages><volume>22</volume><number>3</number><keywords><keyword>Aspergillosis/*epidemiology/mortality</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Incidence</keyword><keyword>Lung Diseases, Fungal/*epidemiology/mortality</keyword><keyword>*Lung Transplantation/methods/mortality</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Morbidity</keyword><keyword>Risk Factors</keyword></keywords><dates><year>2003</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1053-2498 (Print)&#xD;1053-2498 (Linking)</isbn><accession-num>12633692</accession-num><urls><related-urls><url>;[557]. For the remaining patients, inhaled AmB or systemic voriconazole or itraconazole might be equally effective. Posaconazole solution may not be ideal for prophylaxis in the early period after lung transplantation, since many patients have gastrointestinal or nutritional issues, and are taking a proton pump inhibitor as routine post-transplant prophylaxis for gastroesophageal reflux. There are no data on the efficacy and safety of the intravenous or tablet formulations of posaconazole for prophylaxis early after transplant. A benefit to continuing antifungal prophylaxis beyond 3 to 4 months after lung transplant has not been established. Beyond this period of high-risk, we suggest antifungal prophylaxis only in the setting of severe rejection requiring thymoglobulin or alemtuzumab, or high-dose and prolonged use of corticosteroids. What are the recommendations for antifungal prophylaxis in non-lung solid organ transplant recipients?Recommendation72.We recommend prophylactic strategies in solid organ transplant recipients based on the institutional epidemiology of infection and assessment of individual risk factors (Strong Recommendation; Low Quality Evidence).? Prospective trials are lacking to address the need for routine anti-Aspergillus prophylaxis other than for lung transplant recipients.? Individual risk factors have been identified in cardiac (pre-transplant colonization, reoperation, CMV infection, renal dysfunction, institutional outbreak), liver (fulminant hepatic failure, reoperation, retransplantation or renal failure), and others with institutional outbreaks or prolonged or high-dose corticosteroid use.? In such patients, the optimal duration of prophylaxis is not known.? Evidence summaryInvasive Aspergillus infection occurs in up to 19% of all solid organ transplant (SOT) recipients (estimated 0.65% per year) with recent mortality estimates of ~22% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TdGVpbmJhY2g8L0F1dGhvcj48WWVhcj4yMDEyPC9ZZWFy

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ADDIN EN.CITE.DATA [40, 43, 558-560]. The incidence of infection varies with the organ transplanted, including recipients of livers (1-9.2%) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXRlcnNvbjwvQXV0aG9yPjxZZWFyPjE5OTk8L1llYXI+

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ADDIN EN.CITE.DATA [40, 566, 568]. The risks for invasive fungal infection in general, and for Aspergillus infections, are increased by patient-specific factors including the need for organ retransplantation (liver), post-transplant renal or hepatic failure with renal replacement therapy (liver and kidney), re-exploration (liver and heart), pre-transplant colonization with Aspergillus spp. (heart), concurrent CMV infection (liver and heart), hepatitis C infection (liver), and steroid-based regimens PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db2xsaW5zPC9BdXRob3I+PFllYXI+MTk5NDwvWWVhcj48

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Tm90ZT5=

ADDIN EN.CITE.DATA [43, 562, 569-572]. The overall intensity of immunosuppression and the chronicity of systemic illness (malnutrition, hypogammaglobulinemia, and leukopenia) in the organ recipient is a general risk for invasive fungal infection PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXBwYXM8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS

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RW5kTm90ZT4A

ADDIN EN.CITE.DATA [568]. Infections tend to occur both early after transplantation (first month) and late (mean ~184 days) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TaW5naDwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [573-576]. MANAGEMENT OF BREAKTHROUGH INFECTION How should breakthrough aspergillosis be managed?Recommendation73.We suggest an individualized approach that takes into consideration the rapidity and severity of infection and local epidemiology. As principles, we recommend an aggressive and prompt attempt to establish a specific diagnosis with bronchoscopy and/or CT-guided biopsy for peripheral lung lesions. Documentation of serum azole levels should be verified if TDM is available for patients receiving mould-active triazoles. Antifungal therapy should be empirically changed to an alternative class of antifungal with Aspergillus activity. Other considerations include reduction of underlying immunosuppression if feasible, and susceptibility testing of any Aspergillus isolates recovered from the patient (Weak Recommendation; Moderate Quality Evidence).Evidence summary Breakthrough aspergillosis typically occurs in the setting of antifungal prophylaxis. There is a paucity of organized experience on the best way to manage these patients ADDIN EN.CITE <EndNote><Cite><Author>Sipsas</Author><Year>2006</Year><RecNum>179</RecNum><DisplayText>[577]</DisplayText><record><rec-number>179</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412206532">179</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sipsas, N. V.</author><author>Kontoyiannis, D. P.</author></authors></contributors><auth-address>Infectious Diseases Unit, Pathophysiology Department, Laikon General Hospital, Athens, Greece.</auth-address><titles><title>Clinical issues regarding relapsing aspergillosis and the efficacy of secondary antifungal prophylaxis in patients with hematological malignancies</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>1584-91</pages><volume>42</volume><number>11</number><keywords><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Aspergillosis/*drug therapy/*etiology</keyword><keyword>Hematologic Neoplasms/*complications</keyword><keyword>Humans</keyword><keyword>Recurrence</keyword></keywords><dates><year>2006</year><pub-dates><date>Jun 1</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>16652316</accession-num><urls><related-urls><url>;[577]. Documented breakthrough aspergillosis occurs infrequently, in no more than 3% of patients in modern “real life” series of patients receiving mould-active prophylaxis ADDIN EN.CITE <EndNote><Cite><Author>Lerolle</Author><Year>2014</Year><RecNum>177</RecNum><DisplayText>[287]</DisplayText><record><rec-number>177</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412206429">177</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lerolle, N.</author><author>Raffoux, E.</author><author>Socie, G.</author><author>Touratier, S.</author><author>Sauvageon, H.</author><author>Porcher, R.</author><author>Bretagne, S.</author><author>Bergeron, A.</author><author>Azoulay, E.</author><author>Molina, J. M.</author><author>Lafaurie, M.</author></authors></contributors><auth-address>Infectious Diseases Intervention Unit, Hopital Saint-Louis, APHP, University of Paris Diderot Paris 7, Paris, France.</auth-address><titles><title>Breakthrough invasive fungal disease in patients receiving posaconazole primary prophylaxis: a 4-year study</title><secondary-title>Clin Microbiol Infect</secondary-title><alt-title>Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases</alt-title></titles><periodical><full-title>Clinical Microbiology and Infection</full-title><abbr-1>Clin. Microbiol. Infect.</abbr-1><abbr-2>Clin Microbiol Infect</abbr-2><abbr-3>Clinical Microbiology &amp; Infection</abbr-3></periodical><dates><year>2014</year><pub-dates><date>May 26</date></pub-dates></dates><isbn>1469-0691 (Electronic)&#xD;1198-743X (Linking)</isbn><accession-num>24861577</accession-num><urls><related-urls><url>;[287]. If the patient develops breakthrough aspergillosis in the setting of non-mould-active prophylaxis (e.g. fluconazole) , we recommend the same approach for treatment of IA in the absence of prophylaxis. In a patient who develops breakthrough aspergillosis in the setting of mould-active prophylaxis (posaconazole, voriconazole, itraconazole, echinocandins), a “salvage” treatment plan individualized to patient circumstances and comorbidities is required. A typical approach would be to administer broad-spectrum antifungal therapy until the diagnosis is established and a response to treatment can be documented. For patients with apparent breakthrough aspergillosis on prior voriconazole, a lipid formulation of AmB (3-5 mg/kg/d) is recommended, especially in centers where mucormycosis is seen PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFtaWxvczwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+

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ADDIN EN.CITE.DATA [220]. In some countries, breakthrough aspergillosis with multi-triazole resistant Aspergillus species has been described, but the prevalence of these strains in many centers in the United States is unknown ADDIN EN.CITE <EndNote><Cite><Author>Warris</Author><Year>2002</Year><RecNum>181</RecNum><DisplayText>[580]</DisplayText><record><rec-number>181</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412206633">181</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Warris, A.</author><author>Weemaes, C. M.</author><author>Verweij, P. E.</author></authors></contributors><titles><title>Multidrug resistance in Aspergillus fumigatus</title><secondary-title>N Engl J Med</secondary-title><alt-title>The New England journal of medicine</alt-title></titles><periodical><full-title>New England Journal of Medicine</full-title><abbr-1>N. Engl. J. Med.</abbr-1><abbr-2>N Engl J Med</abbr-2></periodical><pages>2173-4</pages><volume>347</volume><number>26</number><keywords><keyword>Antifungal Agents/pharmacology/*therapeutic use</keyword><keyword>Aspergillosis/*drug therapy</keyword><keyword>Aspergillus fumigatus/*drug effects</keyword><keyword>*Aspergillus nidulans</keyword><keyword>Child</keyword><keyword>*Drug Resistance, Multiple, Fungal</keyword><keyword>Granulomatous Disease, Chronic/complications</keyword><keyword>Humans</keyword><keyword>Itraconazole/pharmacology/*therapeutic use</keyword><keyword>Lung Diseases, Fungal/*drug therapy</keyword><keyword>Male</keyword><keyword>Microbial Sensitivity Tests</keyword></keywords><dates><year>2002</year><pub-dates><date>Dec 26</date></pub-dates></dates><isbn>1533-4406 (Electronic)&#xD;0028-4793 (Linking)</isbn><accession-num>12501236</accession-num><urls><related-urls><url>;[580]. The replacement of posaconazole solution with intravenous and extended release tablets may reduce the frequency of extremely low serum concentrations. Further studies are needed to address whether TDM is helpful or necessary with the extended release or intravenous formulations of posaconazole or for isavuconazole. Diagnosis requires the early use of chest/sinus CT and Aspergillus GM, although CT can show atypical lesions PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OdWNjaTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [145] and serum GM is frequently negative or “low positive” in patients receiving mould-active agents pre-exposure. Although the yield of bronchoscopy in these patients might be low, it is recommended as co-infections simulating breakthrough aspergillosis are not uncommon PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HZW9yZ2lhZG91PC9BdXRob3I+PFllYXI+MjAxMjwvWWVh

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ADDIN EN.CITE.DATA [581]. Furthermore, recent data indicate that the yield of GM in BAL is not affected by the presence of a mould-active agent ADDIN EN.CITE <EndNote><Cite><Author>Fisher</Author><Year>2014</Year><RecNum>174</RecNum><DisplayText>[582]</DisplayText><record><rec-number>174</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1412206276">174</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Fisher, C. E.</author><author>Stevens, A. M.</author><author>Leisenring, W.</author><author>Pergam, S. A.</author><author>Boeckh, M.</author><author>Hohl, T. M.</author></authors></contributors><auth-address>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, USA; Division of Allergy and Infectious Diseases, University of Washington, Seattle, Washington, USA.</auth-address><titles><title>Independent contribution of bronchoalveolar lavage and serum galactomannan in the diagnosis of invasive pulmonary aspergillosis</title><secondary-title>Transpl Infect Dis</secondary-title><alt-title>Transplant infectious disease : an official journal of the Transplantation Society</alt-title></titles><periodical><full-title>Transplant Infectious Disease</full-title><abbr-1>Transpl. Infect. Dis.</abbr-1><abbr-2>Transpl Infect Dis</abbr-2></periodical><pages>505-10</pages><volume>16</volume><number>3</number><dates><year>2014</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1399-3062 (Electronic)&#xD;1398-2273 (Linking)</isbn><accession-num>24725139</accession-num><urls><related-urls><url>;[582]. In case there is growth of Aspergillus in a patient with breakthrough Aspergillus pneumonia it would be prudent to document the susceptibility of the cultured isolate (using a reference method) because the patient will?need secondary prophylaxis with a triazole antifungal after the initial treatment phase is completed.VI. When should patients be treated empirically?What strategies are recommended for empirical and pre-emptive strategies in allogeneic HSCT recipients and patients treated for AML? Recommendations74.Empirical antifungal therapy is recommended for high-risk patients with prolonged neutropenia who remain persistently febrile despite broad-spectrum antibiotic therapy. Antifungal options include a lipid formulation of AmB (Strong Recommendation; High Quality Evidence), an echinocandin (caspofungin or micafungin) (Strong Recommendation; High Quality Evidence), or voriconazole (Strong Recommendation; Moderate Quality Evidence). 75.Empirical antifungal therapy is not recommended for patients who are anticipated to have short durations of neutropenia (duration of neutropenia <10 days), unless other findings indicate a suspected invasive fungal infection (Strong Recommendation; Moderate Quality Evidence).76.The use of serum or BAL fungal biomarkers such as GM or (1→3)-β-D-glucan to guide antifungal therapy in asymptomatic or febrile high risk patients (often referred to as pre-emptive or biomarker-driven antifungal therapy) can reduce unnecessary antifungal therapy. The pre-emptive approach can result in more documented cases of IPA without compromise in survival and can be used as an alternative to empirical antifungal therapy (Strong Recommendation; Moderate Quality Evidence).77.Early initiation of antifungal therapy in patients with strongly suspected IPA is warranted while a diagnostic evaluation is conducted (Strong Recommendation; Moderate Quality Evidence). 78.Management of suspected or documented breakthrough IPA in the context of mould-active azole prophylaxis or empirical suppressive therapy is not defined by clinical trial data but a switch to another drug class is suggested (Weak Recommendation; Low Quality Evidence). Evidence summaryThis area has been reviewed in a related 2010 Guideline from the IDSA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GcmVpZmVsZDwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+

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ADDIN EN.CITE.DATA [147, 177, 583-585]. These small randomized, nonplacebo, open-label trials demonstrated that high-risk neutropenic patients with persistent fever despite broad-spectrum antibacterial therapy have an increased risk of developing an overt invasive fungal infection and empirical antifungal therapy reduced the frequency of overt invasive fungal infections. Although all AmB formulations are efficacious, nephrotoxicity and infusion reactions occur and the risk varies by formulation, with the greatest with AmB deoxycholate and least with liposomal AmB. Liposomal AmB and itraconazole were as efficacious as and less toxic than AmB deoxycholate, and caspofungin was as efficacious as liposomal AmB in randomized trials PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWxzaDwvQXV0aG9yPjxZZWFyPjE5OTk8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [586-588]. Although the other echinocandins have been less well studied for this indication, the committee regards all the echinocandins as therapeutically equivalent. A randomized trial of voriconazole versus liposomal AmB did not fulfill criteria for non-inferiority for the overall population but was comparable to liposomal AmB in the high-risk neutropenic population, with a significant reduction in the rate of emergent IA PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XYWxzaDwvQXV0aG9yPjxZZWFyPjIwMDI8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [591] compared antifungal therapy started at the onset of first neutropenic fever with start after 96 hours of fever in leukemic and allogeneic HSCT patients; there was no difference in rates of IFI. The initiation of antifungal therapy is generally recommended for persistent unexplained fever after 4-7 days with a broad-spectrum antibiotic regimen. In one trial, initiation at 4 days was associated with a trend to higher response rates and shorter time to defervescence than initiation at 8 days ADDIN EN.CITE <EndNote><Cite><Author>Malhotra</Author><Year>2014</Year><RecNum>264</RecNum><DisplayText>[592]</DisplayText><record><rec-number>264</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413847819">264</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Malhotra, P.</author><author>Makkar, A.</author><author>Guru Murthy, G. S.</author><author>Varma, N.</author><author>Varma, S.</author><author>Chakrabarti, A.</author></authors></contributors><auth-address>Department of Internal Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India.</auth-address><titles><title>Empirical amphotericin B therapy on day 4 or day 8 of febrile neutropenia</title><secondary-title>Mycoses</secondary-title><alt-title>Mycoses</alt-title></titles><periodical><full-title>Mycoses</full-title><abbr-1>Mycoses</abbr-1><abbr-2>Mycoses</abbr-2></periodical><alt-periodical><full-title>Mycoses</full-title><abbr-1>Mycoses</abbr-1><abbr-2>Mycoses</abbr-2></alt-periodical><pages>110-5</pages><volume>57</volume><number>2</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Amphotericin B/*therapeutic use</keyword><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Drug Therapy/methods</keyword><keyword>Febrile Neutropenia/*drug therapy</keyword><keyword>Female</keyword><keyword>Hematologic Neoplasms/*complications</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Time Factors</keyword><keyword>Treatment Outcome</keyword><keyword>Young Adult</keyword></keywords><dates><year>2014</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1439-0507 (Electronic)&#xD;0933-7407 (Linking)</isbn><accession-num>23844563</accession-num><urls><related-urls><url>;[592]. The use of empiric antifungal therapy still warrants a comprehensive approach to establishing a microbiological diagnosis where feasible.Persistent fever has poor specificity for the diagnosis of an IFI, and empiric antifungal therapy may thus expose patients where antifungal treatment is not indicated. The use of non-invasive diagnostics to detect incipient invasive fungal infections either in asymptomatic at risk patients or in patients with unexplained neutropenic fever is sometimes known as preemptive or biomarker-driven antifungal therapy; the latter is a logical alternative to empiric antifungal therapy, in that it targets a high-risk subpopulation on the basis of a surrogate marker of infection, such as abnormal CT findings or a positive result for GM antigen, (1→3)-β-D-glucan or Aspergillus PCR where available commercially or as a research tool. Biomarkers have been evaluated in two ways: serial screening of asymptomatic high-risk patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWVydGVuczwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+

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ADDIN EN.CITE.DATA [596, 597]. Because ～40% of patients receiving empirical antifungal therapy have pulmonary infiltrates, there is considerable overlap between the approaches of empiric and biomarker-targeted therapy. In a feasibility study, Maertens et al. used serum GM and chest CT to detect IPA in patients with leukemia who received fluconazole prophylaxis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYWVydGVuczwvQXV0aG9yPjxZZWFyPjIwMDU8L1llYXI+

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ADDIN EN.CITE.DATA [593]. This strategy reduced the use of empiric antifungal therapy and successfully treated cases of IPA, in which treatment often was initiated early, before onset of fever. Randomized trials have compared biomarker-driven strategies using serum GM PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UYW48L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxSZWNO

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ADDIN EN.CITE.DATA [595, 597] hamper generalizations. However, in general, these studies suggest that biomarker-driven strategies are associated with less unnecessary antifungal use without a compromise in overall survival. As would be expected by more intensive testing, more invasive fungal infections were generally seen, but without an increase in fungal related mortality, presumably due to early initiation of antifungal therapy made possible by the intensive screening. One concern with the use of PCR assays for screening patients is the lack of commercial assays and technical challenges of different methodologies PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5XaGl0ZTwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [600], the committee does not recommend routine use of PCR assays outside the context of clinical trials or clinical research at this time. These various studies suggest that biomarker-driven antifungal therapy is an acceptable alternative to fever-driven empiric antifungal therapy in patients who are receiving anti-yeast prophylaxis. Further study is needed to clarify which biomarker or combination of biomarkers is optimal, which risk group should be given anti-mould prophylaxis versus biomarker screening, and if routine screening in asymptomatic patients is preferable to screening only febrile patients. Data on biomarkers to guide pre-emptive therapy are limited for pediatric patients.For persistently febrile neutropenic patients who may be receiving anti-Aspergillus prophylaxis, the causes of persistent fever are less likely to be of a fungal origin PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TZWdhbDwvQXV0aG9yPjxZZWFyPjIwMDc8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [601]. Careful evaluation for nonfungal causes, as well as the possibility of breakthrough invasive fungal infections that are resistant to the prophylactic regimen, should be considered in this patient population. Thus, routine initiation of empirical antifungal therapy in this context merits reevaluation.Management of breakthrough IPA in the context of mould-active azole prophylaxis is not defined by clinical trial data. The approach to such patients should be individualized on the basis of clinical criteria, including host immunosuppression, underlying disease, and site of infection, as well as consideration of antifungal dosing, therapeutic monitoring of drug levels, a switch to IV therapy, and/or a switch to another drug class.There are other high risk patients, such as those with refractory leukemia, solid tumors, other solid organ transplant recipients, receiving corticosteroid therapy, liver failure, COPD with progressive infiltrates despite antibiotics and critically ill patients in whom empirical therapy may be warranted on a case by case basis.How do lung transplant recipients differ from other immunosuppressed patients in management of suspected IPA?Recommendations79.In lung transplant recipients not on anti-mould prophylaxis, we suggest pre-emptive therapy with an anti-mould antifungal for asymptomatic patients with Aspergillus colonization of the airways within 6 months of lung transplantation or within 3 months of receiving immunosuppression augmentation for rejection (Weak Recommendation; Moderate Quality Evidence).80.Six months after lung transplantation and in the absence of recent immunosuppression augmentation for rejection, it may be prudent to withhold antifungal therapy for Aspergillus airway colonization (i.e., Aspergillus respiratory cultures in the absence of clinical features that suggest disease, such as compatible symptoms, or bronchoscopic, histopathologic and/or radiographic findings) (Weak Recommendation; Low Quality Evidence).Evidence summaryMany lung transplant centers routinely perform scheduled bronchoscopies with transbronchial biopsies and BAL. These surveillance bronchoscopies allow inspection for airway complications, rejection monitoring, and detection of microbial colonization (bacteria, fungi and/or viruses) before the onset of overt infection. Between 20 to 46% of lung transplant recipients are colonized in the airway with Aspergillus spp. at some point after transplant PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYWhpbGw8L0F1dGhvcj48WWVhcj4xOTk3PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [602, 603]. The risk of IA is increased 11-fold in patients with Aspergillus colonization of the airways, and mortality rates are high PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DYWhpbGw8L0F1dGhvcj48WWVhcj4xOTk3PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [602]. Furthermore, Aspergillus-colonized patients have an increased risk of chronic lung allograft dysfunction due to bronchiolitis obliterans and death PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5JdmVyc2VuPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48

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PgB=

ADDIN EN.CITE.DATA [603, 604]. At present, it is not known whether asymptomatic patients with Aspergillus colonization should be treated with antifungal agents. Given the high rate of Aspergillus disease among colonized patients, we suggest a course of antifungal azole therapy within 6 months of transplant. Pre-emptive antifungal therapy based on culture has been successfully used in clearing Aspergillus from the airway PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OZW9oPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [605-607]. In asymptomatic patients who are colonized with Aspergillus after 6 months, we suggest a thorough physical exam to rule out signs of disseminated aspergillosis, and a chest CT. We also suggest a sinus CT for patients with signs or symptoms of sinus disease. If screening is negative, clinicians should consider factors such as immunosuppression augmentation for rejection within the previous three to four months (especially with alemtuzumab, thymoglobulin, or high dose and prolonged duration of corticosteroids), the presence of recent CMV disease or uncontrolled CMV infection, and the presence of an airway stent or airway abnormalities at the time of positive culture. If physical findings or imaging abnormalities are suggestive of aspergillosis, or any of the aforementioned factors are present, we suggest a course of 1 to 3 months of pre-emptive antifungal therapy and conversely, if negative, a watchful waiting approach without antifungal therapy. CHRONIC AND SAPROPHYTIC SYNDROMES OF ASPERGILLUS VII. How should chronic aspergillosis, allergic or non-invasive syndromes be managed?How can chronic cavitary pulmonary aspergillosis (CCPA) be diagnosed and treated?Recommendations81.??The diagnosis of CCPA requires: (1) 3 months of chronic pulmonary symptoms or chronic illness or progressive radiologic radiographic abnormalities, with cavitation, pleural thickening, peri-cavitary infiltrates and sometimes a fungal ball; (2) Aspergillus IgG antibody elevated or other microbiological data; and (3) no or minimal immunocompromise, usually with one or more underlying pulmonary disorders. The Aspergillus IgG antibody test is the most sensitive microbiological test (Strong Recommendation; Moderate Quality Evidence). Sputum Aspergillus PCR testing is more sensitive than culture (Weak Recommendation; Moderate Quality Evidence).82.Patients with CCPA without pulmonary symptoms, weight loss or significant fatigue, and those without major impairment of pulmonary function or gradual loss of pulmonary function may be observed without antifungal therapy and followed every 3-6 months (Weak Recommendation; Low Quality Evidence).83. Patients with CCPA and either pulmonary or general symptoms or progressive loss of lung function or radiographic progression should be treated with a minimum of 6 months of antifungal therapy (Strong Recommendation; Low Quality Evidence).84. Oral itraconazole and voriconazole are the preferred oral antifungal agents (Strong Recommendation; High Quality Evidence); posaconazole is a useful third-line agent for those with adverse events or clinical failure (Strong Recommendation; Moderate Quality Evidence).85.Hemoptysis may be managed with oral tranexamic acid (Weak Recommendation; Low Quality Evidence), bronchial artery embolization (Strong Recommendation; Moderate Quality Evidence) or antifungal therapy to prevent recurrence (Strong Recommendation; Low Quality Evidence). Patients failing these measures may require surgical resection (Weak Recommendation; Moderate Quality Evidence). 86.In those who fail therapy, who develop triazole resistance and/or have adverse events, intravenous micafungin (Weak Recommendation; Low Quality Evidence), caspofungin (Weak Recommendation; Low Quality Evidence), or AmB (Weak Recommendation; Low Quality Evidence) yield some responses. Treatment may need to be prolonged.87.Surgical resection is an option for some patients with localized disease, unresponsive to medical therapy, including those with pan-azole resistant A. fumigatus infection or persistent hemoptysis despite bronchial artery embolization (Strong Recommendation; Moderate Quality Evidence). The outcomes from surgery are less favorable than those with single aspergilloma, and a careful risk assessment prior to surgical intervention is required. 88.In those with progressive disease, long term, even life-long antifungal therapy may be required to control disease (Weak Recommendation; Low Quality Evidence), with continual monitoring for toxicity and resistance.Evidence summaryChronic cavitary pulmonary aspergillosis (CCPA) is defined as one or more pulmonary cavities which may or may not contain solid or liquid material or a fungal ball, with a positive Aspergillus IgG antibody test or microbiological evidence implicating Aspergillus spp. with significant pulmonary or systemic symptoms and overt radiographic progression (new cavities, increasing pericavity infiltrates or increasing pleural thickening) over at least 3 months PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZW5uaW5nPC9BdXRob3I+PFllYXI+MjAwMzwvWWVhcj48

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ADDIN EN.CITE.DATA [610], single aspergilloma and Aspergillus nodule being others, and chronic fibrosing pulmonary aspergillosis (CFPA) an end stage complication of CCPA. ADDIN EN.CITE <EndNote><Cite><Author>Denning</Author><Year>2003</Year><RecNum>402</RecNum><DisplayText>[608]</DisplayText><record><rec-number>402</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1418941968">402</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Denning, D. W.</author><author>Riniotis, K.</author><author>Dobrashian, R.</author><author>Sambatakou, H.</author></authors></contributors><auth-address>School of Medicine, University of Manchester, Manchester, United Kingdom. ddenning@man.ac.uk</auth-address><titles><title>Chronic cavitary and fibrosing pulmonary and pleural aspergillosis: case series, proposed nomenclature change, and review</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clinical Infectious Diseases</full-title><abbr-1>Clin. Infect. Dis.</abbr-1><abbr-2>Clin Infect Dis</abbr-2></periodical><pages>S265-80</pages><volume>37 Suppl 3</volume><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Aspergillosis/*diagnosis/drug therapy/immunology/surgery</keyword><keyword>Female</keyword><keyword>Fibrosis/etiology</keyword><keyword>Humans</keyword><keyword>Lung Diseases, Fungal/diagnosis/drug therapy/immunology/surgery</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Pleural Diseases/*diagnosis/drug therapy/immunology/surgery</keyword><keyword>Serologic Tests</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2003</year><pub-dates><date>Oct 1</date></pub-dates></dates><isbn>1537-6591 (Electronic)&#xD;1058-4838 (Linking)</isbn><accession-num>12975754</accession-num><urls><related-urls><url>;[608]. CCPA complicates other pulmonary diseases, including tuberculosis, non-tuberculous mycobacterial infection (both of which may occur concurrently, although are usually antecedent), fibrocystic sarcoidosis, ABPA, asthma, prior pneumonia, pneumothorax or lobectomy, chronic obstructive pulmonary disease, ankylosing spondylitis and rheumatoid arthritis, hyper IgE syndrome and congenital bullous disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TbWl0aDwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [587]. Patients are often mistakenly thought to have tuberculosis.If a fungal ball is present on chest imaging, the diagnosis is almost certainly CPA, either a single aspergilloma or CCPA. Confirmation is with Aspergillus IgG testing PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CYXh0ZXI8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [614, 615], and the distinction between these 2 entities made on the basis of symptomology and radiologic appearance. However, the majority of CCPA patients do not have a fungal ball but either multiple empty cavities, or cavities with an irregular (bumpy) internal wall with associated pleural thickening, and peri-cavitary infiltrates. Mats of hyphae within the cavity become dislodged and eventually coalesce to form a fungal ball ADDIN EN.CITE <EndNote><Cite><Author>Roberts</Author><Year>1987</Year><RecNum>509</RecNum><DisplayText>[616]</DisplayText><record><rec-number>509</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1432682030">509</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Roberts, C. M.</author><author>Citron, K. M.</author><author>Strickland, B.</author></authors></contributors><titles><title>Intrathoracic aspergilloma: role of CT in diagnosis and treatment</title><secondary-title>Radiology</secondary-title><alt-title>Radiology</alt-title></titles><periodical><full-title>Radiology</full-title><abbr-1>Radiology</abbr-1><abbr-2>Radiology</abbr-2></periodical><alt-periodical><full-title>Radiology</full-title><abbr-1>Radiology</abbr-1><abbr-2>Radiology</abbr-2></alt-periodical><pages>123-8</pages><volume>165</volume><number>1</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Aged, 80 and over</keyword><keyword>Aspergillosis/pathology/*radiography/surgery</keyword><keyword>Aspergillus/immunology/isolation &amp; purification</keyword><keyword>Diagnosis, Differential</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Lung/pathology/radiography</keyword><keyword>Lung Diseases, Fungal/pathology/*radiography/surgery</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Precipitins/analysis</keyword><keyword>Sputum/microbiology</keyword><keyword>*Tomography, X-Ray Computed/methods</keyword></keywords><dates><year>1987</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>0033-8419 (Print)&#xD;0033-8419 (Linking)</isbn><accession-num>3628758</accession-num><urls><related-urls><url>;[616]. Diagnosis of CCPA is with Aspergillus IgG testing, excluding coccidioidomycosis, histoplasmosis, and paracoccidioidomycosis. Occasionally patients present with mycobacterial infection at the same time as CCPA. Rarely a necrotizing lung cancer can be infected with Aspergillus, giving rise to a similar radiographic appearance. Multiple sputa (expectorated or induced) increase the probability of positive microscopy or fungal culture providing mycological support for the diagnosis. A majority of patients have negative sputum cultures; Aspergillus PCR is more sensitive PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EZW5uaW5nPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48

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ADDIN EN.CITE.DATA [85]. If culture is positive and the patient has been receiving an azole, the isolate should be submitted for susceptibility testing. Hyphae may be seen on microscopy and the culture is negative. Biopsy of the wall of a cavity in CCPA yields chronic inflammatory cells and fibrosis, sometimes with granulomata; hyphae consistent with Aspergillus spp. are usually seen adjacent to the cavity wall, but are not truly invasive. Percutaneous aspiration of a cavity with a positive Aspergillus culture is an alternative means of establishing the diagnosis. Over 50% of patients have an increased total and Aspergillus specific IgE titer; eosinophilia may be present PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb29nYWVydHM8L0F1dGhvcj48WWVhcj4yMDAxPC9ZZWFy

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ADDIN EN.CITE.DATA [587].The objectives of therapy of CCPA are to: 1) improve symptoms, 2) reduce hemoptysis, 3) reduce progressive lung fibrosis, in particular preventing CFPA, which can occur rapidly, and 4) prolong survival. Oral therapy with itraconazole or voriconazole is a first line therapy, depending on tolerance and affordability PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZ2Fyd2FsPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48

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ADDIN EN.CITE.DATA [609, 617-620]. Resistance to itraconazole during therapy has been reported more frequently than with voriconazole, so in patients with a large fungal load, voriconazole may be preferable, although clinical evidence to support this approach is lacking. Posaconazole is currently third line therapy, because of the general lack of data and cost over long periods PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GZWx0b248L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [622]. Monitoring of therapy is critical and should be undertaken by physicians experienced with antifungal therapy. Toxicity may develop with long-term triazole therapy as previously discussed. Occasional patients have a marked increase in shortness of breath shortly after starting antifungal therapy, which may respond to a short course of corticosteroids. Otherwise all steroids should be avoided in CCPA, unless the patients is receiving adequate antifungal therapy and/or requires them for underlying disease, such as those with rheumatoid arthritis. Inhaled corticosteroids should be stopped in those with COPD and reduced in those with asthma, if possible.Hemoptysis can usually be controlled with oral tranexamic acid PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QcnV0c2t5PC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48

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ADDIN EN.CITE.DATA [623, 624]. If hemoptysis is significant, bronchial artery embolization is recommended, and should be performed by an experienced interventional radiologist PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5KYXJkaW48L0F1dGhvcj48WWVhcj4xOTg4PC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [625-628]. It may be necessary to embolize abnormal vessels arising from the internal mammary, subclavian and lateral thoracic arteries as well. Abnormal vessels arising close to the origin of both spinal and vertebral arteries should not be embolized. Recurrence of hemoptysis is common if antifungal therapy is not given and optimized, and may be a sign of antifungal failure.Standard monitoring includes assessing radiographic change (every 3-12 months), preferably with low dose CT without contrast or chest radiograph, inflammatory markers, Aspergillus IgG titers and annual pulmonary function tests. Failure of therapy can be difficult to determine, but is based on a deteriorating clinical status, especially a new productive cough and/or weight loss, new or continuing hemoptysis, radiographic progression, or worsening respiratory function. Other causes of weight loss should be excluded, including celiac disease. Concurrent infection, including non-tuberculous mycobacterial infection, is important to exclude, usually with multiple sputum cultures and occasionally bronchoscopy. Antifungal blood concentrations should be checked. Azole resistance should be sought. On therapy, azole resistance may occur. Susceptibility testing of isolates obtained in patients on therapy may be extremely useful to guide therapeutic choices, and it is recommended that clinical laboratories not discard A. fumigatus isolates for 3 months, to allow clinicians to determine if patients are failing at their next outpatient appointment. Some isolates are only resistant to itraconazole or voriconazole, some to itraconazole and posaconazole and others pan-azole resistant. In patients who fail, are intolerant, or develop azole resistance or a combination of these circumstances, the clinician may need to resort to intravenous therapy. In addition, acutely ill patients may require an initial course of intravenous antifungal therapy. Both AmB deoxycholate and liposomal AmB and micafungin have been extensively used for CCPA, with modest response rates PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2hubzwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [195, 608, 629, 630]. In addition to its anti-Aspergillus activity, liposomal AmB has many TH1 upregulating effects, which are generally deficient in patients with CPA, and may contribute to a clinical response. It is better tolerated than AmB deoxycholate, but both may result in treatment-limiting renal dysfunction. Micafungin has been examined in the treatment of CCPA and found to be effective PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Lb2hubzwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl

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AG==

ADDIN EN.CITE.DATA [195]. There are few data for caspofungin and none for ABLC and ABCD, anidulafungin or isavuconazole PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWlyPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [631]. A common cause of death in CCPA, and possibly a trigger for additional lung fibrosis, is intercurrent bacterial infection. Common infections include: Streptococcus pneumoniae, Haemophilus influenzae and occasionally Pseudomonas aeruginosa and Staphylococcus aureus. Pneumococcal and Haemophilus immunization may reduce infections. Some CCPA patients have overt hypogammaglobulinemia. Pseudomonas aeruginosa eradication or control with high-dose oral ciprofloxacin, intravenous therapy, or inhaled colistin or tobramycin is also recommended for these patients. Minimizing bacterial infections allows simpler decision-making if patients deteriorate on antifungal therapy.Occasionally surgical resection is necessary for CCPA, typically for intractable hemoptysis, destroyed lung (CFPA) with poor quality of life, or azole resistance. Patients need to be fit enough (see section on simple aspergilloma for considerations). A conventional lobectomy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5MZWpheTwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [636-638], or cavernostomy with space reduction using a limited thoracoplasty may be required. The outcomes from surgery are acceptable, but both the risk of death and complications such as pleural space infection is higher in CCPA than for single aspergilloma. Relapse rates up to 25% are documented ADDIN EN.CITE <EndNote><Cite><Author>Farid</Author><Year>2013</Year><RecNum>133</RecNum><DisplayText>[639]</DisplayText><record><rec-number>133</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410380190">133</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Farid, S.</author><author>Mohamed, S.</author><author>Devbhandari, M.</author><author>Kneale, M.</author><author>Richardson, M.</author><author>Soon, S. Y.</author><author>Jones, M. T.</author><author>Krysiak, P.</author><author>Shah, R.</author><author>Denning, D. W.</author><author>Rammohan, K.</author></authors></contributors><titles><title>Results of surgery for chronic pulmonary Aspergillosis, optimal antifungal therapy and proposed high risk factors for recurrence--a National Centre&apos;s experience</title><secondary-title>J Cardiothorac Surg</secondary-title><alt-title>Journal of cardiothoracic surgery</alt-title></titles><periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></periodical><alt-periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></alt-periodical><pages>180</pages><volume>8</volume><dates><year>2013</year></dates><isbn>1749-8090 (Electronic)&#xD;1749-8090 (Linking)</isbn><accession-num>23915502</accession-num><urls><related-urls><url>;[639], which makes decision making difficult, especially in the knowledge that subtle immune deficits will persist after surgery. All CCPA patients undergoing resection surgery require active follow up. What are the management options for an Aspergillus fungal ball of the lung (aspergilloma)?Recommendations89.Asymptomatic patients with a single aspergilloma and no progression of the cavity size over 6-24 months should continue to be observed (Strong Recommendation; Moderate Quality Evidence).90.Patients with symptoms, especially significant hemoptysis, with a single aspergilloma, should have it resected, assuming that there are no contraindications (Strong Recommendation; Moderate Quality Evidence).91.Peri/post-operative antifungal therapy is not routinely required, but if the risk of surgical spillage of the aspergilloma is moderate (related to location and morphology of the cavity) antifungal therapy with voriconazole (or another mould active azole) or an echinocandin is suggested to prevent Aspergillus empyema (Weak Recommendation; Low Quality Evidence). Evidence summarySingle aspergilloma, previously often referred to as simple aspergilloma, may occur with chronic pulmonary aspergillosis (CPA) so that the evidence supporting management of a fungal ball due to Aspergillus should be considered in the context of CPA in that situation. These patients may be asymptomatic, present with hemoptysis, shortness of breath or cough. “Single uncomplicated aspergilloma” is defined as a single pulmonary cavity containing a fungal ball in a non-immunocompromised patient with microbiological or serological evidence of Aspergillus spp. with minimal or no symptoms and no radiographic progression over at least 3 months PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TbWl0aDwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [636-638]. However surgical planning requires the following considerations ADDIN EN.CITE <EndNote><Cite><Author>Farid</Author><Year>2013</Year><RecNum>133</RecNum><DisplayText>[639]</DisplayText><record><rec-number>133</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410380190">133</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Farid, S.</author><author>Mohamed, S.</author><author>Devbhandari, M.</author><author>Kneale, M.</author><author>Richardson, M.</author><author>Soon, S. Y.</author><author>Jones, M. T.</author><author>Krysiak, P.</author><author>Shah, R.</author><author>Denning, D. W.</author><author>Rammohan, K.</author></authors></contributors><titles><title>Results of surgery for chronic pulmonary Aspergillosis, optimal antifungal therapy and proposed high risk factors for recurrence--a National Centre&apos;s experience</title><secondary-title>J Cardiothorac Surg</secondary-title><alt-title>Journal of cardiothoracic surgery</alt-title></titles><periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></periodical><alt-periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></alt-periodical><pages>180</pages><volume>8</volume><dates><year>2013</year></dates><isbn>1749-8090 (Electronic)&#xD;1749-8090 (Linking)</isbn><accession-num>23915502</accession-num><urls><related-urls><url>;[639]: respiratory reserve should be adequate, as based on FEV1 and especially exercise tolerance; patients who are taking anti-thrombotic medication should be able to have their medication suspended for at least 4 days, and preferably longer; and pre-operative bronchial artery embolization allows more time for surgical assessment and planning, but has little impact on post-operative bleeding ADDIN EN.CITE <EndNote><Cite><Author>Alexander</Author><Year>2014</Year><RecNum>134</RecNum><DisplayText>[640]</DisplayText><record><rec-number>134</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410381003">134</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Alexander, G. R.</author></authors></contributors><auth-address>Inkosi Albert Luthuli Central Hospital, Durban, South Africa.</auth-address><titles><title>A retrospective review comparing the treatment outcomes of emergency lung resection for massive haemoptysis with and without preoperative bronchial artery embolization</title><secondary-title>Eur J Cardiothorac Surg</secondary-title><alt-title>European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery</alt-title></titles><periodical><full-title>European Journal of Cardio-Thoracic Surgery</full-title><abbr-1>Eur. J. Cardiothorac. Surg.</abbr-1><abbr-2>Eur J Cardiothorac Surg</abbr-2></periodical><pages>251-5</pages><volume>45</volume><number>2</number><dates><year>2014</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1873-734X (Electronic)&#xD;1010-7940 (Linking)</isbn><accession-num>23918766</accession-num><urls><related-urls><url>;[640]. An evaluation of risk of spillage at surgery needs to be made based on the difficulty of separating the cavity containing the fungal ball from the chest wall ADDIN EN.CITE <EndNote><Cite><Author>Farid</Author><Year>2013</Year><RecNum>133</RecNum><DisplayText>[639]</DisplayText><record><rec-number>133</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410380190">133</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Farid, S.</author><author>Mohamed, S.</author><author>Devbhandari, M.</author><author>Kneale, M.</author><author>Richardson, M.</author><author>Soon, S. Y.</author><author>Jones, M. T.</author><author>Krysiak, P.</author><author>Shah, R.</author><author>Denning, D. W.</author><author>Rammohan, K.</author></authors></contributors><titles><title>Results of surgery for chronic pulmonary Aspergillosis, optimal antifungal therapy and proposed high risk factors for recurrence--a National Centre&apos;s experience</title><secondary-title>J Cardiothorac Surg</secondary-title><alt-title>Journal of cardiothoracic surgery</alt-title></titles><periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></periodical><alt-periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></alt-periodical><pages>180</pages><volume>8</volume><dates><year>2013</year></dates><isbn>1749-8090 (Electronic)&#xD;1749-8090 (Linking)</isbn><accession-num>23915502</accession-num><urls><related-urls><url>;[639]. Extrapleural dissection over the apex may be required but may be followed by bleeding from collateral arterial vessels crossing the pleura from the chest wall. If it is likely or possible that the cavity will be opened during the surgical procedure, leading to pleural contamination, then antifungal therapy with voriconazole (or another mould active azole) or micafungin (or another echinocandin) should be given, starting pre-operatively with voriconazole or peri-operatively for micafungin. Use of voriconazole may alter the preferred anesthetic approach as prolongation of benzodiazepine sedation is problematic with voriconazole. If no spillage occurs during surgery, antifungal therapy can be stopped. If spillage does occur, some clinicians advise washing out the pleural space with AmB or antifungal topical disinfectant such as taurolodine 2%, although evidence to support either approach is minimal. Antifungal therapy should be continued post-operatively and an infectious disease physician involved in care to monitor therapy, and determine the length of treatment. If there is no evidence of infection following spillage during surgery, a minimum of 4 weeks of therapy is typically recommended. Patients with 2 separate aspergillomas ADDIN EN.CITE <EndNote><Cite><Author>Pendleton</Author><Year>2012</Year><RecNum>135</RecNum><DisplayText>[641]</DisplayText><record><rec-number>135</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410381079">135</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pendleton, M.</author><author>Denning, D. W.</author></authors></contributors><auth-address>Ninewells Hospital and Medical School, University of Dundee, Dundee, United Kingdom.</auth-address><titles><title>Multifocal pulmonary aspergillomas: case series and review</title><secondary-title>Ann N Y Acad Sci</secondary-title><alt-title>Annals of the New York Academy of Sciences</alt-title></titles><periodical><full-title>Annals of the New York Academy of Sciences</full-title><abbr-1>Ann. N. Y. Acad. Sci.</abbr-1><abbr-2>Ann N Y Acad Sci</abbr-2></periodical><alt-periodical><full-title>Annals of the New York Academy of Sciences</full-title><abbr-1>Ann. N. Y. Acad. Sci.</abbr-1><abbr-2>Ann N Y Acad Sci</abbr-2></alt-periodical><pages>58-67</pages><volume>1272</volume><keywords><keyword>Adrenal Cortex Hormones/pharmacology/therapeutic use</keyword><keyword>Adult</keyword><keyword>Antifungal Agents/*therapeutic use</keyword><keyword>Azoles/pharmacology/therapeutic use</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Pulmonary Aspergillosis/*drug therapy/pathology</keyword></keywords><dates><year>2012</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>1749-6632 (Electronic)&#xD;0077-8923 (Linking)</isbn><accession-num>23231715</accession-num><urls><related-urls><url>;[641] may be considered for bi-lobar resections or pneumonectomy depending on locations and their respiratory reserve. If respiratory reserve does not allow resection, then medical therapy alone can be offered to minimize recurrent hemoptysis.Relapse following resection does occur, with 25% of patients in one CPA series had relapse of infection including some aspergilloma cases ADDIN EN.CITE <EndNote><Cite><Author>Farid</Author><Year>2013</Year><RecNum>133</RecNum><DisplayText>[639]</DisplayText><record><rec-number>133</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410380190">133</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Farid, S.</author><author>Mohamed, S.</author><author>Devbhandari, M.</author><author>Kneale, M.</author><author>Richardson, M.</author><author>Soon, S. Y.</author><author>Jones, M. T.</author><author>Krysiak, P.</author><author>Shah, R.</author><author>Denning, D. W.</author><author>Rammohan, K.</author></authors></contributors><titles><title>Results of surgery for chronic pulmonary Aspergillosis, optimal antifungal therapy and proposed high risk factors for recurrence--a National Centre&apos;s experience</title><secondary-title>J Cardiothorac Surg</secondary-title><alt-title>Journal of cardiothoracic surgery</alt-title></titles><periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></periodical><alt-periodical><full-title>Journal of Cardiothoracic Surgery</full-title><abbr-1>J. Cardiothorac. Surg.</abbr-1><abbr-2>J Cardiothorac Surg</abbr-2></alt-periodical><pages>180</pages><volume>8</volume><dates><year>2013</year></dates><isbn>1749-8090 (Electronic)&#xD;1749-8090 (Linking)</isbn><accession-num>23915502</accession-num><urls><related-urls><url>;[639]. Most surgical series do not provide long term follow up. For patients with spillage, active follow up, typically at 4-6 month intervals assessing radiographic change, inflammatory markers and Aspergillus IgG titers for 3 years is advised. If spillage has not occurred, then active follow up is not advised, unless there is ongoing active pulmonary disease.ALLERGIC SYNDROMES OF ASPERGILLUSHow is ABPA identified and managed, in patients with asthma and CF?Recommendations92.Elevated Aspergillus IgE and total IgE are recommended to establish the diagnosis and are useful for screening (Strong Recommendation; High Quality Evidence).93.We suggest treating symptomatic asthmatic patients with bronchiectasis or mucoid impaction, despite oral or inhaled corticosteroid therapy, with oral itraconazole therapy with therapeutic drug monitoring (Weak Recommendation; Low Quality Evidence).94.In CF patients with frequent exacerbations and/or falling FEV1, we suggest treating with oral itraconazole to minimize corticosteroid use with therapeutic drug monitoring, and consideration of other mould-active azole therapy if therapeutic levels cannot be achieved. 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ADDIN EN.CITE.DATA [83, 515, 642, 643]. In asthmatic patients it presents as poorly controlled asthma, ‘pneumonia’ which represents mucoid impaction, persistent eosinophilia, and bronchiectasis or with chronic pulmonary aspergillosis and lung fibrosis, the latter both late complications. Some patients are asymptomatic. In CF, it tends to present with difficult to control exacerbations, responsive to corticosteroids, although mucoid impaction is described. The key criterion for diagnosis is an elevated Aspergillus-specific IgE, supported by an elevated total IgE, detectable Aspergillus specific IgG, eosinophilia, and positive skin prick tests for Aspergillus (where available) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZ2Fyd2FsPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48

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ADDIN EN.CITE.DATA [83, 643, 644]. Uncommonly other fungi can produce a similar clinical picture. Patients with severe asthma, not fulfilling the criteria for ABPA may have severe asthma with fungal sensitization (SAFS), also responsive to antifungal therapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LbnV0c2VuPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48

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ADDIN EN.CITE.DATA [642, 645]. There are some areas of overlap with these syndromes, and some experts consider all patients with these diagnoses under the term ‘fungal asthma’. Screening for ABPA in patients with asthma and CF, probably on an annual basis, is recommended, particularly if patients are symptomatic with frequent asthma exacerbations. Asthmatics admitted to hospital, including intensive care, should be evaluated for fungal asthma PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BZ2Fyd2FsPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48

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ADDIN EN.CITE.DATA [643, 645, 647]. Treatment involves a 2-pronged approach: controlling the immune response (which is what makes the patient symptomatic), and decreasing the burden of organisms so that there is less of an immune response. Oral corticosteroids reduce the inflammatory response in acute exacerbations of ABPA, but are associated with many adverse effects, some short-term, others long-term, such as diabetes in CF. Relapse is frequent after discontinuation. Inhaled corticosteroids control asthma in some patients. Anti-IgE (Omalizumab) therapy might be helpful, data are scant ADDIN EN.CITE <EndNote><Cite><Author>Tanou</Author><Year>2014</Year><RecNum>221</RecNum><DisplayText>[648]</DisplayText><record><rec-number>221</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1413831313">221</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tanou, K.</author><author>Zintzaras, E.</author><author>Kaditis, A. G.</author></authors></contributors><auth-address>Pediatric Pulmonology Unit, First Department of Pediatrics, University of Athens School of Medicine and Aghia Sophia Children&apos;s Hospital, Athens, Greece.</auth-address><titles><title>Omalizumab therapy for allergic bronchopulmonary aspergillosis in children with cystic fibrosis: a synthesis of published evidence</title><secondary-title>Pediatr Pulmonol</secondary-title><alt-title>Pediatric pulmonology</alt-title></titles><periodical><full-title>Pediatric Pulmonology</full-title><abbr-1>Pediatr. Pulmonol.</abbr-1><abbr-2>Pediatr Pulmonol</abbr-2></periodical><alt-periodical><full-title>Pediatric Pulmonology</full-title><abbr-1>Pediatr. Pulmonol.</abbr-1><abbr-2>Pediatr Pulmonol</abbr-2></alt-periodical><pages>503-7</pages><volume>49</volume><number>5</number><dates><year>2014</year><pub-dates><date>May</date></pub-dates></dates><isbn>1099-0496 (Electronic)&#xD;1099-0496 (Linking)</isbn><accession-num>24167019</accession-num><urls><related-urls><url>;[648]. Cough and sputum production may be reduced by azithromycin or antifungal therapy or both. Nebulized hypertonic saline helps some patients’ clear sputum PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LZWxsZXR0PC9BdXRob3I+PFllYXI+MjAwNTwvWWVhcj48

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ADDIN EN.CITE.DATA [649]. Prevention of exacerbations may be effected by pneumococcal and/or Haemophilus vaccination. Avoidance of substantial fungal exposures, as in composting, farming and house renovation may also prevent exacerbations. Antifungal therapy is helpful for many patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Nb3NzPC9BdXRob3I+PFllYXI+MjAxNDwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [645, 647, 650, 651]. Itraconazole is currently the first line agent for symptomatic patients, CF patients with low FEV1 or those with complications such as bronchiectasis, mucoid impaction or chronic pulmonary aspergillosis. Itraconazole solution is preferred in CF patients because of poor absorption of capsules. Patients who fail itraconazole, or are intolerant to itraconazole, may respond to voriconazole, posaconazole or inhaled AmB ADDIN EN.CITE <EndNote><Cite><Author>Chishimba</Author><Year>2014</Year><RecNum>508</RecNum><DisplayText>[652]</DisplayText><record><rec-number>508</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1432681558">508</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chishimba, L.</author><author>Langridge, P.</author><author>Powell, G.</author><author>Niven, R. M.</author><author>Denning, D. W.</author></authors></contributors><auth-address>Manchester Academic Health Science Centre, University Hospital South Manchester NHS Foundation Trust, The University of Manchester , Manchester , UK .</auth-address><titles><title>Efficacy and safety of nebulised amphotericin B (NAB) in severe asthma with fungal sensitisation (SAFS) and allergic bronchopulmonary aspergillosis (ABPA)</title><secondary-title>J Asthma</secondary-title><alt-title>The Journal of asthma : official journal of the Association for the Care of Asthma</alt-title></titles><periodical><full-title>Journal of Asthma</full-title><abbr-1>J. Asthma</abbr-1><abbr-2>J Asthma</abbr-2></periodical><pages>1-7</pages><dates><year>2014</year><pub-dates><date>Sep 23</date></pub-dates></dates><isbn>1532-4303 (Electronic)&#xD;0277-0903 (Linking)</isbn><accession-num>25158109</accession-num><urls><related-urls><url>;[652]. Relapse after improvement during antifungal therapy is common; long term suppressive therapy may be necessary. Interactions of itraconazole with some inhaled corticosteroids can precipitate Cushing’s syndrome, so that reduction in inhaled steroid dose, or a switch to ciclesonide may be useful for those patients. Triazole antifungal resistance has been documented in some geographic regions, so susceptibility testing may be valuable in areas where epidemiologic data indicates environmental resistance or isolates are cultured from patients on antifungal therapy. What is the medical management of allergic fungal rhinosinusitis caused by Aspergillus spp.?Recommendations95.We recommend establishing the diagnosis of allergic fungal rhinosinusitis (AFRS) in patients with nasal polyposis and thick eosinophilic mucin by visualizing hyphae in mucus, which is supported by a positive Aspergillus IgE serum assay or skin prick test (where available) (Strong Recommendation; Moderate Quality Evidence). 96.We recommend polypectomy and sinus washout as the optimal means of symptom control and inducing remission, however relapse is frequent (Strong Recommendation; Moderate Quality Evidence).97.We recommend the use of topical nasal steroids to reduce symptoms and increase time to relapse, especially if given after surgery (Strong Recommendation; Moderate Quality Evidence).98.We suggest oral antifungal therapy using mould-active triazoles for refractory infection and/or rapidly relapsing disease, although this approach is only partially effective (Weak Recommendation; Low Quality Evidence).Evidence summaryAllergic fungal rhinosinusitis (AFRS) is a small subset (<10%) of chronic rhinosinusitis occurring in adults and children PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFuZzwvQXV0aG9yPjxZZWFyPjIwMTM8L1llYXI+PFJl

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ADDIN EN.CITE.DATA [653]. AFRS characterized by eosinophilic mucin and fungal hyphae in the paranasal sinuses, often associated with immediate hypersensitivity to various fungi. Fungal culture of nasal secretions is usually unhelpful as it reflects airborne fungi, so clarity about the specific fungus involved is usually inferential or unclear. The disease is commonly associated with nasal polyposis, and sometimes with ABPA ADDIN EN.CITE <EndNote><Cite><Author>Thompson</Author><Year>2012</Year><RecNum>428</RecNum><DisplayText>[654]</DisplayText><record><rec-number>428</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1419013945">428</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Thompson, G. R., 3rd</author><author>Patterson, T. F.</author></authors></contributors><auth-address>Department of Medical Microbiology and Immunology, Coccidioidomycosis Serology Laboratory, University of California-Davis, Davis, Calif 95616, USA. grthompson@ucdavis.edu.</auth-address><titles><title>Fungal disease of the nose and paranasal sinuses</title><secondary-title>J Allergy Clin Immunol</secondary-title><alt-title>The Journal of allergy and clinical immunology</alt-title></titles><periodical><full-title>Journal of Allergy and Clinical Immunology</full-title><abbr-1>J. Allergy Clin. Immunol.</abbr-1><abbr-2>J Allergy Clin Immunol</abbr-2><abbr-3>Journal of Allergy &amp; Clinical Immunology</abbr-3></periodical><pages>321-6</pages><volume>129</volume><number>2</number><keywords><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Humans</keyword><keyword>*Mycoses/diagnosis/drug therapy/microbiology</keyword><keyword>*Nose Diseases/diagnosis/drug therapy/microbiology</keyword><keyword>Paranasal Sinus Diseases/diagnosis/drug therapy/microbiology</keyword></keywords><dates><year>2012</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1097-6825 (Electronic)&#xD;0091-6749 (Linking)</isbn><accession-num>22206776</accession-num><urls><related-urls><url>;[654]. Local complications of AFRS include ophthalmic involvement with oculomotor palsy, bony erosion, cavernous venous thrombosis ADDIN EN.CITE <EndNote><Cite><Author>Bozeman</Author><Year>2011</Year><RecNum>119</RecNum><DisplayText>[655]</DisplayText><record><rec-number>119</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410378846">119</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bozeman, S.</author><author>deShazo, R.</author><author>Stringer, S.</author><author>Wright, L.</author></authors></contributors><auth-address>Department of Medicine, University of Mississippi Medical Center, Jackson, MS, USA.</auth-address><titles><title>Complications of allergic fungal sinusitis</title><secondary-title>Am J Med</secondary-title><alt-title>The American journal of medicine</alt-title></titles><periodical><full-title>American Journal of Medicine</full-title><abbr-1>Am. J. Med.</abbr-1><abbr-2>Am J Med</abbr-2></periodical><pages>359-68</pages><volume>124</volume><number>4</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Anti-Inflammatory Agents/therapeutic use</keyword><keyword>Antifungal Agents/therapeutic use</keyword><keyword>Child</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hypersensitivity/complications/drug therapy/*microbiology</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Mycoses/complications/drug therapy/*immunology/*microbiology</keyword><keyword>Paranasal Sinuses/immunology/microbiology/pathology</keyword><keyword>Prednisone/therapeutic use</keyword><keyword>Sinusitis/complications/drug therapy/*microbiology</keyword><keyword>Young Adult</keyword></keywords><dates><year>2011</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1555-7162 (Electronic)&#xD;0002-9343 (Linking)</isbn><accession-num>21435427</accession-num><urls><related-urls><url>;[655]. The disease course is long with many patients having extended periods of remission with exacerbations often following viral and/or bacterial infections. Short courses of modest doses of oral corticosteroids may shrink polyps and allow drainage, but relapse is common, and not usually prevented by topical steroids. Surgical removal of polyps and mucus is the most important aspect of management, with postoperative systemic or topical nasal steroids recommended to reduce the time to relapse PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ib3dhcmQ8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS

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ADDIN EN.CITE.DATA [656, 657]. Saline washes are often helpful. Omaluzimab has been reported to be helpful in studies of severe asthma with associated chronic rhinitis ADDIN EN.CITE <EndNote><Cite><Author>Tsabouri</Author><Year>2014</Year><RecNum>136</RecNum><DisplayText>[658]</DisplayText><record><rec-number>136</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1410384889">136</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tsabouri, S.</author><author>Tseretopoulou, X.</author><author>Priftis, K.</author><author>Ntzani, E. E.</author></authors></contributors><auth-address>Department of Paediatrics, University of Ioannina School of Medicine, Ioannina, Greece.&#xD;Evidence-based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.&#xD;Third Department of Paediatrics, University of Athens School of Medicine, Attikon University Hospital, Athens, Greece.&#xD;Evidence-based Medicine Unit, Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece. Electronic address: entzani@cc.uoi.gr.</auth-address><titles><title>Omalizumab for the treatment of inadequately controlled allergic rhinitis: a systematic review and meta-analysis of randomized clinical trials</title><secondary-title>J Allergy Clin Immunol Pract</secondary-title><alt-title>The journal of allergy and clinical immunology. In practice</alt-title></titles><periodical><full-title>J Allergy Clin Immunol Pract</full-title></periodical><pages>332-40 e1</pages><volume>2</volume><number>3</number><dates><year>2014</year><pub-dates><date>May-Jun</date></pub-dates></dates><isbn>2213-2201 (Electronic)</isbn><accession-num>24811026</accession-num><urls><related-urls><url>;[658]. Oral antifungal therapy for AFRS, usually itraconazole, is helpful for refractory disease and to prevent relapse in patients with frequent recurrences PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5DaGFuPC9BdXRob3I+PFllYXI+MjAwODwvWWVhcj48UmVj

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ADDIN EN.CITE.DATA [659-661]. FUTURE DIRECTIONSThere are many unanswered and unresolved epidemiological, laboratory, and clinical questions that need to be addressed and understood in the diagnosis, treatment and prevention of aspergillosis. Better diagnostic tests and improved understanding of the optimal use of current methods are needed both to facilitate more accurate identification of patients with IA and to permit earlier initiation of therapy. The availability of more active and better tolerated antifungal agents has significantly improved therapy of patients at risk for serious Aspergillus infections, but even with optimal antifungal therapy the mortality rate remains high so that further development of new antifungal agents is greatly needed. Critical gaps in knowledge remain regarding management of these infections including the optimal utility of combination therapy, tools for early detection of these infections, evaluation of response, therapy for patients with breakthrough or refractory infection and the patient population for whom prophylaxis would be most beneficial.NOTESAcknowledgements. The expert panel expresses its gratitude for thoughtful reviews of an earlier version by Sanjay Revankar and Samuel Lee. The Panel also greatly appreciates the work of Charles B. Wessels and Michele Klein Fedyshin of the Health Sciences Library System of the University of Pittsburgh for the development and execution of the systematic literature searches for this guideline. We would like to give special thanks to Genet Demisashi for her support in the development of this guideline. Financial support.Support for this guideline was provided by the Infectious Diseases Society of America.Potential conflicts of interest.The following list is a re?ection of what has been reported to IDSA. To provide thorough transparency, IDSA requires full disclosure of all relationships, regardless of relevancy to the guideline topic. Evaluation of such relationships as potential con?icts of interest (COI) is determined by a review process that includes assessment by the SPGC Chair, the SPGC liaison to the development panel, and the Board of Directors liaison to the SPGC and, if necessary, the COI Task Force of the Board. This assessment of disclosed relationships for possible COI will be based on the relative weight of the ?nancial relationship (i.e., monetary amount) and the relevance of the relationship (i.e., the degree to which an association might reasonably be interpreted by an independent observer as related to the topic or recommendation of consideration). The reader of these guidelines should be mindful of this when the list of disclosures is reviewed. For activities outside of the submitted work, T.F.P. received research grant support to the University of Texas Health Science Center San Antonio from Astellas, Merck, and Revolution Medicines and has been a consultant for or served on advisory board to Amplyx, Astellas, Durata, Cidara Therapeutics, Gilead, Merck, Pfizer, Revolution Medicines, Scynexis, Toyama, Vical, and Viamet. For activities outside of the submitted work, G.R.T. received research support to the University of California – Davis from Astellas, Merck, Pfizer, and Scynexis, and has been a consultant for Astellas. For activities outside of the submitted work, D.W.D. holds Founder shares in F2G Ltd a University of Manchester spin-out antifungal discovery company, has current grant support from the National Institute of Health Research, Medical Research Council, Global Action Fund for Fungal Infections, the Fungal Infection Trust, serves as a consultant to Astellas, Sigma Tau, Basilea and Pulmocide and has received honorarium from Astellas, Dynamiker, Gilead, Merck and Pfizer. For activities outside of the submitted work, J.A.F. served on scientific advisory boards for Revolution Medicines. For activities outside of the submitted work, S.H. served as a consultant to Merck. For activities outside of the submitted work, R.H. served on advisory boards for Astellas, Basilea, Gilead Sciences, Pfizer and received research grants from Alsace contre le Cancer and Pfizer. For activities outside of the submitted work, D.P.K. served as consultant to Astellas, Merck, and Pfizer, received research support for Astellas, Merck, Pfizer and T2 Biosystems and received honorarium from Astellas, Merck, Pfizer, T2 Biosystems, Gilead and F2G, Inc. For activities outside of the submitted work, K.A.M. received honorarium from Amplyx, Astellas, Cidara, F2G, Merck, Pfizer, Revolutions Medicine and Vical. In addition, Dr. Marr has a patent US No. 13/511,264 licensed. For activities outside of the submitted work, V.A.M. served as a consultant for Celgene, Amgen, GSK, Merck, and Astellas, and served as speaker’s bureau for Genentech and Celgene. For activities outside of the submitted work, M.H.N. received research grants from Astellas, Pfizer, Merck, and ViraCor and National Institute of Health (NIAID). For activities outside of the submitted work, B.H.S. served on advisory boards for Merck and Astellas, and has contracts for laboratory research from Astellas and Assembly Biosciences. For activities outside of the submitted work, W.J.S. served on scientific advisory boards and received research grants to Duke University from Merck. For activities outside of the submitted work, T.J.W. served as a consultant or scientific advisor for Astellas, Novartis, Pfizer, and Methlygene and received research grants to Weill Cornell Medical Center from Astellas, Merck, and Novartis. For activities outside of the submitted work, J.R.W. served as consultant/scientific advisor for Gilead, Astellas, Pfizer, Merck and Vical, J.H.Y. received research support to the University of Minnesota from Astellas Pharma US Inc., Merck, and Pfizer. J.E.B., D.A.S., no conflicts.TABLES & FIGURESFigure SEQ Figure \* ARABIC 1: Approach and implications to rating the quality of evidence and strength of recommendations using the GRADE methodology (unrestricted use of the figure granted by the U.S. GRADE Network) ADDIN EN.CITE <EndNote><Cite ExcludeAuth="1" ExcludeYear="1"><RecNum>1113</RecNum><DisplayText>[4]</DisplayText><record><rec-number>1113</rec-number><foreign-keys><key app="EN" db-id="25ws99rfnw2zfmert5rxzapsprpa5wr2efdr" timestamp="1461689151">1113</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors></contributors><titles><title>U.S. GRADE Network. Approach and implications to rating the quality of evidence and strength of recommendations using the GRADE methodology. Available at: . Accessed April, 2016</title></titles><dates></dates><urls></urls></record></Cite></EndNote>[4]Table 1. Summary of recommendations for the treatment of aspergillosisCondition7874030162500TherapyInvasive syndromes of AspergillusPrimaryAlternativeCommentsIPAVoriconazole (6 mg/kg IV every 12 h for 1 day, followed by 4 mg/kg IV every 12 h; oral therapy can be used at 200-300 mg every 12 h or weight based dosing on a mg/kg basis); see text for pediatric dosingPrimary: Liposomal AmB (3-5 mg/kg/day IV), isavuconazole 200 mg every 8 h for 6 doses, then 200 mg dailySalvage: ABLC (5 mg/kg/day IV), caspofungin (70 mg/day IV x 1, then 50 mg/day IV thereafter), micafungin (100-150 mg/day IV), posaconazole (Oral suspension: 200 mg TID; Tablet: 300 mg BID on day 1, then 300 mg daily, IV: 300 mg BID on day 1, then 300 mg daily, itraconazole suspension (200 mg PO every 12 h)Primary combination therapy is not routinely recommended; addition of another agent or switch to another drug class for salvage therapy may be considered in individual patients; dosage in pediatric patients for voriconazole and for caspofungin is different than that of adults; limited clinical experience is reported with anidulafungin; dos- age of posaconazole in pediatric patients has not been definedInvasive sinus aspergillosisSimilar to IPASimilar to IPASurgical debridement as an adjunct to medical therapyTracheobronchial aspergillosisSimilar to IPAAdjunctive inhaled AmB may be usefulSimilar to IPAAspergillosis of the CNSSimilar to IPASimilar to IPASurgical resection may be beneficial in selected casesThis infection is associated with the highest mortality among all of the different patterns of IA; drug interactions with anticonvulsant therapyAspergillus infections of the heart (endocarditis, pericardi- tis, and myocarditis)Similar to IPA Similar to IPA Endocardial lesions caused by Aspergillus species require surgical resection; Aspergillus pericarditis usually requires pericardiectomyAspergillus osteomyelitis and septic arthritisSimilar to IPA Similar to IPASurgical resection of devitalized bone and cartilage is important for curative intentAspergillus infections of the eye (endophthalmitis and keratitis)Systemic IV or oral voriconazole plus intraocular AmB or voriconazole indicated with partial vitrectomySimilar to invasive pulmonary aspergillo- sis; limited data with echinocandins and poor ocular penetration by this classSystemic therapy may be beneficial in management of aspergillus endophthalmitis; ophthalmologic intervention and management is recommended for all forms of ocular infection; topical therapy for keratitis is indicatedCutaneous aspergillosisSimilar to IPASimilar to IPASurgical resection is indicated where feasibleAspergillus peritonitisSimilar to IPASimilar to IPARemoval of peritoneal dialysis catheter is essential Empirical and preemptive antifungal therapyFor empirical antifungal therapy, Liposomal AmB (3 mg/kg/day IV), caspofungin (70 mg day 1 IV and 50 mg/day IV thereafter), itraconazole (200 mg PO BID), Voriconazole (6 mg/kg IV every 12 h for 1 day, followed by 4 mg/kg IV every 12 h; oral therapy can be used at 200-300 mg every 12 h or 3-4mg/kg q 12 h) Preemptive therapy is a logical extension of empirical antifungal therapy in defining a high-risk population with evidence of invasive fungal infection (e.g., pulmonary infiltrate or positive GM assay result)Prophylaxis against IAPosaconazole:Oral suspension: 200 mg TIDTablet: 300 mg BID on day 1, then 300 mg dailyIV: 300 mg BID on day 1, then 300 mg dailyItraconazole suspension (200 mg PO every 12 h); micafungin (50 mg /day)Efficacy of posaconazole prophylaxis demonstrated in high-risk patients (patients with GVHD and neutropenic patients with AML or MDS)Saprophytic or colonizing syndromes of AspergillusPrimaryAlternativeCommentsAspergillomaNo therapy or surgical resectionItraconazole or voriconazole; similar to IPAThe role of medical therapy in the treatment of aspergilloma is uncertain; penetration into preexisting cavities may be minimal for AMB Chronic cavitary pulmonary aspergillosisSimilar to IPASimilar to IPAInnate immune defects demonstrated in most of these patients; long-term therapy may be needed; surgical resection may lead to significant complications; anecdotal response to IFN-γ. Tranexamic acid may be helpful in management of hemoptysisAllergic Syndromes of AspergillosisPrimaryAlternativeCommentsABPAItraconazoleOral voriconazole (200 mg PO every 12 h) or posaconazole (dosage depends on formulation)Corticosteroids are a cornerstone of therapy for exacerbations; itraconazole has a demonstrable corticosteroid-sparing effectAllergic rhinosinusitis caused by AspergillusPolypectomy and sinus washout with intranasal corticosteroidsAntifungal therapy reserved for refractory or relapsing casesAbbreviations: IV, intravenous; PO, per os. AmB, amphotericin B; ABLC, amphotericin B lipid complex; CNS, Central nervous system; GVHD, graft versus host diseases; AML, acute myeloid leukemia, MDS, myelodysplastic syndrome; IFN-γ, interferon gammaTable 2. Clinical scenarios where therapeutic drug monitoring is useful in treatment of aspergillosis. Clinical scenarios where antifungal therapeutic drug monitoring is usefulExamples, commentPopulations with increased pharmacokinetic variabilityImpaired gastrointestinal function; hepatic (voriconazole, posaconazole, itraconazole); pediatric patients, elderly patients, obese patients, critically-ill patientsChanging pharmacokineticsIntravenous to oral switch, changing GI function, changing hepatic or renal function, physiological-instabilityInteracting medicationsPatient receiving medication that induce CYP3A4, antacids, proton-pump inhibitors (itraconazole capsules, posaconazole suspension), antiretroviral medicationsPossibly corticosteroids (voriconazole)Severe diseaseExtensive infection, lesions contiguous with critical structures, CNS infection, multifocal or disseminated infectionComplianceImportant issue with longer-term consolidation therapy or secondary prophylaxisSuspected breakthrough infectionTDM can help to establish whether fungal disease progression occurred in the setting of inadequate antifungal exposureSuspected drug toxicity, especially neurotoxicity (voriconazole)Although exposure-response relationships are described for other toxicities (e.g., hepatotoxicity, bone disease), the utility of TDM to prevent their occurrence is less well establishedTable developed from (Andes et al. 2009; Ashbee et al. 2013)NB: Additional studies are needed to assess role of TDM for isavuconazole and for posaconazole extended tablet and intravenous formulations. TDM, therapeutic drug monitoring; CNS, central nervous system; GI, gastrointestinalTable 3. Commonly encountered drug-drug interactions during treatment of aspergillosis. Agent/ClassInteractionCommentCalcineurin inhibitors (CNI) and mammalian target of rapamycin inhibitors (mTOR) immunosuppressive agents Significant increase in CNI levels by azole CNI and mTOR agents should be reduced (~30-50% for CNI and > for rapamycin) at the time of initiating azole therapy and serum levels for both agents monitored until steady state is reached. Stopping of CNI or mTOR may provoke graft rejection. CorticosteroidsLevels are increased by azolesMay exacerbate immune-suppression favorable for fungal growth. Prolonged co-administration may elicit signs of excessive steroid exposure. Antiretroviral agents for HIVVariable effectsFrequently used in combination with other classes of agents; monitoring of azole levels recommended, and bidirectional drug-drug interactions common. Rifampin/rifabutinDecreased levels of azole agents while rifampin/rifabutin levels are increased Combined use of voriconazole, posaconazole, isavuconazole, or itraconazole with rifampin/rifabutin should generally be avoided. Some combinations are considered contraindicated; others may be managed by TDM and dose adjustment.Agents which cause QTc interval prolongation (fluoroquinolone and macrolide antimicrobials, quinine, quinidine, digoxin, amiodarone and other antiarrhythmic drugs, calcium channel blockers, psychiatric drugs, antihistamines, cocaine and other agents)QT interval prolongation, torsades de pointes and other cardiac arrhythmias have been observed with azoles in combination with other agents or preexisting conditions that have these effectsAssess risk benefit and. administer with caution to patients with cardiac disorders that increase the risk of arrhythmias.Vincristine and other vinca alkaloid agentsNeurotoxicity including peripheral neuropathy and seizures in combination with azoles; azole levels also increasedGiven the potential for serious toxicity, vincristine and other vinca alkaloids should generally not be co-administered with mould-active azoles. 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