Multicenter randomized trial of fluconazole versus amphotericin B for treatment of candidemia in non-neutropenic patients
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 to Candida glabrata or Candida 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% CI, -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% CI, -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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Two large randomized studies and 2 large observational studies have demonstrated that fluconazole (400 mg/day) and amphotericin B deoxycholate (0.5-0.6 mg/kg per day) are similarly effective as therapy.
“Two large randomized studies [105, 106] and 2 large observational studies [107, 108] have demonstrated that fluconazole (400 mg/day) and amphotericin B deoxycholate (0.5-0.6 mg/kg per day) are similarly effective as therapy.”
From Guidelines for Treatment of Candidiasis (2004) · cites this paper as [106]
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- Authors
- Phillips, P., Shafran, S., Garber, G., Rotstein, C., Smaill, F., Fong, I., Salit, I., Miller, M., Williams, K., Conly, J. M., Singer, J., Ioannou, S., & for the Canadian Candidemia Study Group
- Affiliations
- University of British Columbia (CA)
- University of Alberta (CA)
- University of Ottawa (CA)
- Juravinski Hospital (CA)
- McMaster University Medical Centre (CA)
- St. Michael's Hospital (CA)
- Toronto General Hospital (CA)
- Jewish General Hospital (CA)
- Royal University Hospital (CA)
- Pfizer (Canada) (CA)
- Venue
- European Journal of Clinical Microbiology & Infectious Diseases
- Published
- 1997-05
- Volume
- 16
- Issue
- 5
- Pages
- 337-345
- ISSN
- 0934-9723 (ISSN-L)
- 1435-4373
- OpenAlex
- W1971099675
- Cited by
- 221
- References
- 32
- Citations by year
- 2026: 1 · 2025: 1 · 2023: 1 · 2022: 1 · 2021: 2 · 2020: 1 · 2019: 6 · 2018: 4 · 2017: 2 · 2016: 2 · 2015: 6 · 2014: 4 · 2013: 7 · 2012: 8
- FWCI
- 3.43
- Type
- journal article
- Language
- en
- Open access
- closed
- Licence
- www.springer.com/tdm (tdm)
- Locations
- European Journal of Clinical Microbiology & Infectious Diseases (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Alberta
- Topics
- Health Sciences › Medicine › Infectious Diseases › Antifungal resistance and susceptibility
- Health Sciences › Medicine › Epidemiology › Fungal Infections and Studies
- Health Sciences › Medicine › Ophthalmology › Ocular Infections and Treatments
- Keywords
- candidemia, fluconazole, amphotericin B, non-neutropenic patients, antifungal therapy, Candida glabrata, Candida krusei, drug-related adverse events, mortality, treatment efficacy
- MeSH terms
- Adult, Aged, Amphotericin B, Antifungal Agents, Candidiasis, Female, Humans, Immunocompetence, Male, Middle Aged, Fluconazole, Survival Rate, Confidence Intervals, Fungemia, Treatment Outcome
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