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

Brahm H. Segal, Raoul Herbrecht, David A. Stevens, Luis Ostrosky-Zeichner, Jack Sobel, Claudio Viscoli, Thomas J. Walsh, Johan Maertens, Thomas F. Patterson, John R. Perfect, Bertrand Dupont, John R. Wingard, Thierry Calandra, Carol A. Kauffman, John R. Graybill, Lindsey R. Baden, Peter G. Pappas, John E. Bennett, Dimitrios P. Kontoyiannis, Catherine Cordonnier & 10 others Maria Anna Viviani, Jacques Bille, Nikolaos G. Almyroudis, L. Joseph Wheat, Wolfgang Graninger, Eric J. Bow, Steven M. Holland, Bart Jan Kullberg, William E. Dismukes, Ben E. De Pauw

Research output: Contribution to journalArticle

239 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)674-683
Number of pages10
JournalClinical Infectious Diseases
Volume47
Issue number5
DOIs
Publication statusPublished - Sep 1 2008

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Mycoses
Outcome Assessment (Health Care)
Clinical Trials
Organizations
Research
Neoplasms
Therapeutics
Coccidioides
Histoplasma
Cryptococcus neoformans
Immunocompromised Host
Aspergillus
Treatment Failure
Candida
Fungi
Guidelines
Morbidity
Mortality

ASJC Scopus subject areas

  • Immunology

Cite this

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. / Segal, Brahm H.; 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; Viviani, Maria Anna; Bille, Jacques; Almyroudis, Nikolaos G.; Wheat, L. Joseph; Graninger, Wolfgang; Bow, Eric J.; Holland, Steven M.; Kullberg, Bart Jan; Dismukes, William E.; De Pauw, Ben E.

In: Clinical Infectious Diseases, Vol. 47, No. 5, 01.09.2008, p. 674-683.

Research output: Contribution to journalArticle

Segal, BH, Herbrecht, R, Stevens, DA, Ostrosky-Zeichner, L, Sobel, J, Viscoli, C, Walsh, TJ, Maertens, J, Patterson, TF, Perfect, JR, Dupont, B, Wingard, JR, Calandra, T, Kauffman, CA, Graybill, JR, Baden, LR, Pappas, PG, Bennett, JE, Kontoyiannis, DP, Cordonnier, C, Viviani, MA, Bille, J, Almyroudis, NG, Wheat, LJ, Graninger, W, Bow, EJ, Holland, SM, Kullberg, BJ, Dismukes, WE & De Pauw, BE 2008, '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', Clinical Infectious Diseases, vol. 47, no. 5, pp. 674-683. https://doi.org/10.1086/590566
Segal, Brahm H. ; 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 ; Viviani, Maria Anna ; Bille, Jacques ; Almyroudis, Nikolaos G. ; Wheat, L. Joseph ; Graninger, Wolfgang ; Bow, Eric J. ; Holland, Steven M. ; Kullberg, Bart Jan ; Dismukes, William E. ; De Pauw, Ben E. / 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. In: Clinical Infectious Diseases. 2008 ; Vol. 47, No. 5. pp. 674-683.
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