Forum report: Issues in the design of trials of drugs for the treatment of invasive aspergillosis

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

Research output: Contribution to journalArticle

6 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)S113-S116
JournalClinical Infectious Diseases
Volume36
Issue numberSUPPL. 3
DOIs
StatePublished - Apr 15 2003

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

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    Bennett, J. E., Powers, J., De Pauw, B., Dismukes, W., Galgiani, J., Glauser, M., Herbrecht, R., Kauffman, C., Lee, J., Pappas, P., Rex, J., Verweii, P., Viscoli, C., & Walsh, T. (2003). Forum report: Issues in the design of trials of drugs for the treatment of invasive aspergillosis. Clinical Infectious Diseases, 36(SUPPL. 3), S113-S116. https://doi.org/10.1086/367838