Journal Article

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 and Paul Verweij

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 36, issue Supplement_3, pages S117-S122
Published in print April 2003 | ISSN: 1058-4838
Published online April 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/367839
Forum Report: Issues in Clinical Trials of Empirical Antifungal Therapy in Treating Febrile Neutropenic Patients

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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.

Journal Article.  4311 words. 

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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