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

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 tha...

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Published in:Clinical infectious diseases Vol. 36; no. 10; p. 1221
Main Authors: Rex, John H, Pappas, Peter G, Karchmer, Adolf W, Sobel, Jack, Edwards, John E, Hadley, Susan, Brass, Corstiaan, Vazquez, Jose A, Chapman, Stanley W, Horowitz, Harold W, Zervos, Marcus, McKinsey, David, Lee, Jeannette, Babinchak, Timothy, Bradsher, Robert W, Cleary, John D, Cohen, David M, Danziger, Larry, Goldman, Mitchell, Goodman, Jesse, Hilton, Eileen, Hyslop, Newton E, Kett, Daniel H, Lutz, Jon, Rubin, Robert H, Scheld, W Michael, Schuster, Mindy, Simmons, Bryan, Stein, David K, Washburn, Ronald G, Mautner, Linda, Chu, Teng-Chiao, Panzer, Helene, Rosenstein, Rebecca B, Booth, Jenia
Format: Journal Article
Language:English
Published: United States 15.05.2003
Subjects:
Adult
Amphotericin B - adverse effects
Amphotericin B - therapeutic use
Antifungal Agents - adverse effects
Antifungal Agents - therapeutic use
Candida - drug effects
Candidiasis - drug therapy
Candidiasis - physiopathology
Catheterization
Double-Blind Method
Drug Therapy, Combination
Female
Fluconazole - adverse effects
Fluconazole - therapeutic use
Fungemia - drug therapy
Fungemia - physiopathology
Humans
Male
Middle Aged
Neutropenia - etiology
Treatment Outcome
ISSN:1537-6591, 1537-6591
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Summary: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.
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ISSN:1537-6591
1537-6591
DOI:10.1086/374850