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| Content Provider | Springer Nature Link |
|---|---|
| Author | Phillips, P. Shafran, S. Garber, G. Rotstein, C. Smaill, F. Fong, I. Salit, I. Miller, M. Williams, K. Conly, J. M. Singer, J. Ioanu, S. |
| Copyright Year | 1997 |
| 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. |
| Starting Page | 337 |
| Ending Page | 345 |
| Page Count | 9 |
| File Format | |
| ISSN | 09349723 |
| Journal | European Journal of Clinical Microbiology & Infectious Diseases |
| Volume Number | 16 |
| Issue Number | 5 |
| e-ISSN | 14354373 |
| Language | English |
| Publisher | Springer-Verlag |
| Publisher Date | 1997-01-01 |
| Publisher Place | Berlin, Heidelberg |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Medical Microbiology Internal Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Infectious Diseases Microbiology (medical) |
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