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Invasive Fungal Infections- Diagnostic Criteria

Invasive Fungal Infections- Diagnostic Criteria

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Published by Andreas Ioannou

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Published by: Andreas Ioannou on Feb 13, 2013
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07/29/2013

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Defining Responses to Therapy and Study Outcomes in Clinical Trials of InvasiveFungal Infections: Mycoses Study Group (MSG) and European Organization forResearch and Treatment of Cancer (EORTC) Consensus CriteriaContributors:
Brahm H. Segal, MD, Raoul Herbrecht, MD, David A. Stevens MD, Luis Ostrosky-ZeichnerMD, Jack Sobel MD, Claudio Viscoli MD, Thomas J. Walsh MD,Johan Maertens MD, Thomas F. Patterson MD, John R. Perfect MD, Bertrand Dupont MD,John R. Wingard MD, Thierry Calandra MD, Carol Kauffman MD,John R. Graybill MD, Lindsey Baden MD, Peter G. Pappas MD, John E. Bennett MD,Dimitrios P. Kontoyiannis MD, Catherine Cordonnier MD, Maria Anna Viviani MD,Elias J. Anaissie MD, Jacques Bille, MD, Nikolaos G. Almyroudis MD, Joseph Wheat MD,Wolfgang Graninger MD, Eric J. Bow MD, Juan C. Gea-Banacloche MD, Steven M.HollandMD, Bart-Jan Kullberg MD, William E. Dismukes, MD and Ben E. De Pauw MD.
e-mail comments to: brahm.segal@roswellpark.org
 
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Abstract
Invasive fungal infections (IFI) have become a major cause of morbidity and mortality in highlyimmunocompromised patients. Authoritative consensus criteria
 
to diagnose IFIs have recentlybeen established and have been useful in establishing eligibility criteria for antifungal trials. There isan important need for generating consensus definitions of outcomes of IFIs that will form astandard for evaluating treatment success and failure in clinical trials. Therefore, an expertinternational panel consisting of the Mycoses Study Group (MSG) and European Organization forResearch and Treatment of Cancer (EORTC) and other experts was convened to proposeguidelines for assessing treatment responses in clinical trials of IFI and defining study outcomes.Major fungal infections that are discussed include invasive disease due to
Candida
species,
 Aspergillus
species, other moulds,
Cryptococcus neoformans
, histoplasmosis andcoccidioidomycosis. Potential pitfalls in assessing outcome, such as conflicting clinical radiological,and/or mycological data, and gaps in knowledge are discussed.
 
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Introduction
 Invasive fungal infections (IFIs) have become a major cause of morbidity and mortality inhighly immunocompromised patients. The European Organization for Research and Treatmentof Cancer (EORTC) and the Mycoses Study Group (MSG) published international consensusguidelines on definitions of IFIs to ensure standardization between trials [1]. These guidelines ormodified versions have been widely used as eligibility criteria in clinical trials and are currentlyundergoing revision.Just as controversies exist in the definition of IFIs, there is also considerable debate as tohow a successful response to therapy should be defined. The design of the trial and studyendpoints must be focused on demonstrating the benefit and safety of a new therapy in thespecific setting that it is being evaluated. Fulfilling pre-specified study endpoints is a pre-requisitefor drug approval.Bennett and colleagues discussed the important challenges in the design of clinical antifungaltrials [2-4]. Our objective is to generate consensus definitions of outcomes of IFIs that will forma standard for evaluating treatment success and failure in future clinical trials. Aspects of studydesign that are directly linked to evaluating treatment responses are discussed. In constructingthese criteria, we have tried to address potential limitations in previously employed definitions.Reflecting the “bias” of our panel that is chiefly comprised of clinician investigators who care forimmunocompromised patients, we have tried to construct definitions of study outcomes that thepracticing physician would find most meaningful.The proposed response criteria will be restricted to antifungal trials of established IFIs,and will not address prophylactic or empirical antifungal trials. The first section addressesgeneral challenges and pitfalls in assessing responses in antifungal trials. In the second section,

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