Journal Article

A Randomized and Blinded Multicenter Trial of High-Dose Fluconazole plus Placebo versus Fluconazole plus Amphotericin B as Therapy for Candidemia and Its Consequences in Nonneutropenic Subjects

John H. Rex, Peter G. Pappas, Adolf W. Karchmer, Jack Sobel, John E. Edwards, Susan Hadley, Corstiaan Brass, Jose A. Vazquez, Stanley W. Chapman, Harold W. Horowitz, Marcus Zervos, David McKinsey, Jeannette Lee, Timothy Babinchak, Robert W. Bradsher, John D. Cleary, David M. Cohen, Larry Danziger, Mitchell Goldman, Jesse Goodman, Eileen Hilton, Newton E. Hyslop, Daniel H. Kett, Jon Lutz, Robert H. Rubin, W. Michael Scheld, Mindy Schuster, Bryan Simmons, David K. Stein, Ronald G. Washburn, Linda Mautner, Teng-Chiao Chu, Helene Panzer, Rebecca B. Rosenstein and Jenia Booth

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 36, issue 10, pages 1221-1228
Published in print May 2003 | ISSN: 1058-4838
Published online May 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/374850
A Randomized and Blinded Multicenter Trial of High-Dose Fluconazole plus Placebo versus Fluconazole plus Amphotericin B as Therapy for Candidemia and Its Consequences in Nonneutropenic Subjects

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A randomized, blinded, multicenter trial was conducted to compare fluconazole (800 mg per day) plus placebo with fluconazole plus amphotericin B (AmB) deoxycholate (0.7 mg/kg per day, with the placebo/AmB component given only for the first 5–6 days) as therapy for candidemia due to species other than Candida krusei in adults without neutropenia. A total of 219 patients met criteria for a modified intent-to-treat analysis. The groups were similar except that those who were treated with fluconazole plus placebo had a higher mean (± standard error) Acute Physiology and Chronic Health Evaluation II score (16.8 ± 0.6 vs. 15.0 ± 0.7; P = .039). Success rates on study day 30 by Kaplan-Meier time-to-failure analysis were 57% for fluconazole plus placebo and 69% for fluconazole plus AmB (P = .08). Overall success rates were 56% (60 of 107 patients) and 69% (77 of 112 patients; P = .043), respectively; the bloodstream infection failed to clear in 17% and 6% of subjects, respectively (P = .02). In nonneutropenic subjects, the combination of fluconazole plus AmB was not antagonistic compared with fluconazole alone, and the combination trended toward improved success and more-rapid clearance from the bloodstream.

Journal Article.  4277 words.  Illustrated.

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

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