Forum report: Issues in clinical trials of empirical antifungal therapy in treating febrile neutropenic patients

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

Research output: Contribution to journalArticle

55 Scopus citations

Abstract

There is inferential evidence that some patients with prolonged neutropenia and fever not responding to antibacterial agents are at sufficient risk of deep mycoses to warrant empirical therapy, although superiority of an antifungal agent over placebo has not been conclusively demonstrated. Amphotericin B deoxycholate, liposomal amphotericin B, and intravenous itraconazole followed by oral itraconazole solution are licensed in the United States for this indication. Fluconazole and voriconazole have given favorable results in clinical trials of patients with low and high risk of deep mold infections, respectively. Design features that can profoundly influence outcome of empirical trials are (1) inclusion of low-risk patients, (2) failure to blind the study, (3) obscuration of antifungal effects by changing antibacterial antibiotics, (4) failure to balance both arms of the study in terms of patients with prior antifungal prophylaxis or with severe comorbidities, (5) the merging of end points evaluating safety with those of efficacy, and (6) choice of different criteria for resolution of fever.

Original languageEnglish (US)
Pages (from-to)S117-S122
JournalClinical Infectious Diseases
Volume36
Issue numberSUPPL. 3
DOIs
StatePublished - Apr 15 2003

    Fingerprint

ASJC Scopus subject areas

  • Microbiology (medical)
  • Infectious Diseases

Cite this

Bennett, J. E., Powers, J., Walsh, T., Viscoli, C., De Pauw, B., Dismukes, W., Galgiani, J., Glauser, M., Herbrecht, R., Kauffman, C., Lee, J., Pappas, P., Rex, J., & Verweij, P. (2003). Forum report: Issues in clinical trials of empirical antifungal therapy in treating febrile neutropenic patients. Clinical Infectious Diseases, 36(SUPPL. 3), S117-S122. https://doi.org/10.1086/367839