Multicenter randomized trial of fluconazole versus amphotericin B for treatment of candidemia in non-neutropenic patients |
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| Authors: | P. Phillips S. Shafran G. Garber C. Rotstein F. Smaill I. Fong I. Salit M. Miller K. Williams J. M. Conly J. Singer S. Ioannou |
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| Affiliation: | (1) Division of Infectious Diseases, St. Paul's Hospital and the University of British Columbia, 667-1081 Burrard Street, V6Z l Y6 Vancouver, British Columbia, Canada;(2) Division of Infectious Diseases, University of Alberta, 2E4.11 Walter MacKenzie Centre, 8440-112 Street, T6G 2B7 Edmonton, Alberta, Canada;(3) Division of Infectious Diseases, Ottawa General Hospital, University of Ottawa, 501 Smythe Road, K1H 8L6 Ottawa, Ontario, Canada;(4) Division of Infectious Diseases, McMaster Medical Unit, Henderson General Hospital, 711 Concession Street, L8V 1C3 Hamilton, Ontario, Canada;(5) Division of Infectious Diseases, McMaster University Medical Centre, 2N29-1200 Main Street West, L8N 3Z5 Hamilton, Ontario, Canada;(6) St. Michael's Hospital, 30 Bond Street, MSB 1W8 Toronto, Ontario, Canada;(7) Division of Infectious Diseases, Toronto General Hospital, 101 College Street, College Wing, Ground Floor, Room 325, M5G 1L7 Toronto, Ontario, Canada;(8) Department of Medical Microbiology, Jewish General Hospital, G-142, 3755 Cote-Ste-Catherine, H3T 1E2 Montreal, Quebec, Canada;(9) Division of Infectious Diseases, Royal University Hospital, S7N 0X0 Saskatoon, Saskatchewan, Canada;(10) Toronto Hospital, 200 Elizabeth Street, M5G 2C4 Toronto, Ontario, Canada;(11) Department of Health Care and Epidemiology, University of British Columbia, 5th floor - 1081 Burrard Street, V6Z 1 Y6 Vancouver, British Columbia, Canada;(12) Pfizer Canada, Inc., P O Box 800, H9R 4V2 Point Claire, Quebec, Canada |
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| Abstract: | A randomized trial was conducted to compare the efficacy and safety of fluconazole versus that of amphotericin B in the treatment of candidemia in non-neutropenic adults. Enrollment was stratified by disease severity (APACHE II score). Patients were randomized (1 :1) to receive amphotericin B 0.6 mg/kg/day (cumulative dose 8 mg/kg) or fluconazole 800 mg intravenous loading dose, then 400 mg daily for four weeks (intravenous for at least 10 days). Patients were monitored for six months. A total of 106 patients were enrolled. A protocol amendment implemented midway through the trial required patients to be removed from the study and treated with amphotericin B if species identification indicated candidemia due toCandida glabrata orCandida krusei. Baseline characteristics were similar for the two groups; 103 patients (fluconazole, 50; amphotericin B, 53) met the major enrollment criteria. The intention-to-treat analysis indicated successful therapy in 50% of fluconazole recipients compared to 58% of the amphotericin B group (p=0.39; one-sided 95% Cl, –8 to 24%). The efficacy analysis included 84 patients (fluconazole, 42; amphotericin B, 42); successful outcomes were observed in 57% and 62% of cases in the fluconazole and amphotericin B groups, respectively (p=0.66: one-sided 95% Cl, –12 to 22%). The mortality at day 14 for the fluconazole group was 26% and for the amphotericin B group 21% (p=0.52; chi-square test) and remained similar throughout the course of follow-up. Drug-related adverse events were more frequent with amphotericin B than with fluconazole and prompted switching of therapy for two (4%) and zero cases, respectively. Fluconazole and amphotericin B were associated with similar clinical response rates and survival in the treatment of candidemia among non-neutropenic patients; however, drug-related adverse events were more frequent with amphotericin B. |
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