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Defining responses to therapy and study outcomes in clinical trials of invasive fungal diseases: Mycoses Study Group and European Organization for Research and Treatment of Cancer consensus criteria.

Authors
  • Segal, Brahm H1
  • Herbrecht, Raoul
  • Stevens, David A
  • Ostrosky-Zeichner, Luis
  • Sobel, Jack
  • Viscoli, Claudio
  • Walsh, Thomas J
  • Maertens, Johan
  • Patterson, Thomas F
  • Perfect, John R
  • Dupont, Bertrand
  • Wingard, John R
  • Calandra, Thierry
  • Kauffman, Carol A
  • Graybill, John R
  • Baden, Lindsey R
  • Pappas, Peter G
  • Bennett, John E
  • Kontoyiannis, Dimitrios P
  • Cordonnier, Catherine
  • And 10 more
  • 1 Department of Medicine, Roswell Park Cancer Institute, Buffalo, New York 14263, USA. [email protected]
Type
Published Article
Journal
Clinical Infectious Diseases
Publisher
Oxford University Press
Publication Date
Sep 01, 2008
Volume
47
Issue
5
Pages
674–683
Identifiers
DOI: 10.1086/590566
PMID: 18637757
Source
Medline
License
Unknown

Abstract

Invasive fungal diseases (IFDs) have become major causes of morbidity and mortality among highly immunocompromised patients. Authoritative consensus criteria to diagnose IFD have been useful in establishing eligibility criteria for antifungal trials. There is an important need for generation of consensus definitions of outcomes of IFD that will form a standard for evaluating treatment success and failure in clinical trials. Therefore, an expert international panel consisting of the Mycoses Study Group and the European Organization for Research and Treatment of Cancer was convened to propose guidelines for assessing treatment responses in clinical trials of IFDs and for defining study outcomes. Major fungal diseases that are discussed include invasive disease due to Candida species, Aspergillus species and other molds, Cryptococcus neoformans, Histoplasma capsulatum, and Coccidioides immitis. We also discuss potential pitfalls in assessing outcome, such as conflicting clinical, radiological, and/or mycological data and gaps in knowledge.

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