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Forum Report: Issues in the Design of Trials of Drugs for the Treatment of Invasive Aspergillosis

Bennett, John E. ; Powers, John ; de Pauw, Ben ; Dismukes, William ; Galgiani, John ; Glauser, Michel ; Herbrecht, Raoul ; Kauffman, Carol ; Lee, Jeannette ; Pappas, Peter ; Rex, John ; Verweij, Paul ; Viscoli, Claudio ; Walsh, Thomas

In: Clinical Infectious Diseases, 2003, vol. 36, no. Supplement_3, p. S113-S116

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    Titre
    • Forum Report: Issues in the Design of Trials of Drugs for the Treatment of Invasive Aspergillosis
    Auteur
    • Bennett, John E.. Clinical Mycology Section, Laboratory of Clinical Investigation, National Institute of Allergy and Infectious Diseases, Bethesda
    • Powers, John. Division of Special Pathogen and Immunologic Drug Products, US Food and Drug Administration, Rockville, Maryland
    • de Pauw, Ben. University Hospital St. Radboud, Nijmegen, Netherlands
    • Dismukes, William. University of Alabama, Birmingham
    • Galgiani, John. VA Medical Center and University of Arizona, Tucson
    • Glauser, Michel. University Hospital, Lausanne, Switzerland
    • Herbrecht, Raoul. Hôpital de Hautepierre, Strasbourg, France
    • Kauffman, Carol. VA Medical Center and University of Michigan, Ann Arbor
    • Lee, Jeannette. University of Alabama, Birmingham
    • Pappas, Peter. University of Alabama, Birmingham
    • Rex, John. University of Texas Medical School, Houston
    • Verweij, Paul. University Hospital St. Radboud, Nijmegen, Netherlands
    • Viscoli, Claudio. University of Genoa, National Institute for Cancer Research, Italy
    • Walsh, Thomas. National Cancer Institute, National Institutes of Health, Bethesda
    Type de document
    • Postprint
    Langue
    • Anglais
    Publié dans
    • Clinical Infectious Diseases, 2003, vol. 36, no. Supplement_3, p. S113-S116. The University of Chicago Press
    Autre version électronique
    Classification
    • Santé
    Identifiant OAI-PMH
    • oai:doc.rero.ch:299956
    Summary
    A recent trial of drugs for invasive aspergillosis was used as a background for discussing critical features in the design of antifungal trials. The study under discussion allowed stopping either drug without classifying the patient as having treatment failure, so the trial should be understood as a comparison of 2 treatment strategies, not just 2 drugs. Although the study was a noninferiority trial, the outcome permitted a claim of superiority. Use of the category of "probable” in addition to "proven” aspergillosis permitted inclusion of patients for whom the diagnosis was less certain but who were still early enough in the disease progression to respond to therapy. Different opinions still exist about some of the criteria for the diagnosis of "probable” aspergillosis. A blinded data review committee was helpful in evaluating efficacy in this unblinded trial but had limited value in assessing toxicity. An understanding of these features of design of antifungal drug trials is important in applying the results to clinical practice