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
In: Clinical Infectious Diseases, Jg. 36 (2003-05-15), S. 1221-1228
Online
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Zugriff:
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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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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Autor/in / Beteiligte Person: | Danziger, Larry H. ; Kett, Daniel H. ; Simmons, Bryan P. ; Schuster, Mindy G. ; Cleary, John D. ; Chu, Teng-Chiao ; Mautner, Linda ; Sobel, Jack D. ; Panzer, Helene ; McKinsey, David S. ; Hilton, Eileen ; Zervos, Marcus J. ; Washburn, Ronald G. ; Vazquez, Jose A. ; Hyslop, Newton E. ; Babinchak, Timothy ; Goodman, Jesse L. ; Brass, Corstiaan ; Rubin, Robert H. ; Cohen, David M. ; Pappas, Peter G. ; Lee, Jeannette Y. ; Booth, Jenia ; Horowitz, Harold W. ; Stein, David K. ; Rosenstein, Rebecca B. ; Lutz, Jon E. ; Goldman, Mitchell ; W. Michael Scheld ; Hadley, Susan ; Edwards, John E. ; Bradsher, Robert W. ; Rex, John H. ; Chapman, Stanley W. ; Karchmer, Adolf W. |
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Zeitschrift: | Clinical Infectious Diseases, Jg. 36 (2003-05-15), S. 1221-1228 |
Veröffentlichung: | Oxford University Press (OUP), 2003 |
Medientyp: | unknown |
ISSN: | 1537-6591 (print) ; 1058-4838 (print) |
DOI: | 10.1086/374850 |
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