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Clinical Trial
. 1994 Nov 17;331(20):1325-30.
doi: 10.1056/NEJM199411173312001.

A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. Candidemia Study Group and the National Institute

J H Rex  1 , J E Bennett, A M Sugar, P G Pappas, C M van der Horst, J E Edwards, R G Washburn, W M Scheld, A W Karchmer, A P Dine, et al.
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Free article
Clinical Trial

A randomized trial comparing fluconazole with amphotericin B for the treatment of candidemia in patients without neutropenia. Candidemia Study Group and the National Institute

J H Rex et al. N Engl J Med. .
Free article

Abstract

Background: Amphotericin B has long been the standard treatment for candidemia, but its use is complicated by its toxicity. More recently, fluconazole, a water-soluble triazole with activity against candida species and little toxicity, has become available. We conducted a multicenter randomized trial that compared amphotericin B with fluconazole as treatment for candidemia.

Methods: To be eligible, patients had to have a positive blood culture for candida species, a neutrophil count > or = 500 per cubic millimeter, and no major immunodeficiency. Patients were randomly assigned to receive either amphotericin B (0.5 to 0.6 mg per kilogram of body weight per day) or fluconazole (400 mg per day), each continued for at least 14 days after the last positive blood culture. Outcomes were assessed by a group of investigators blinded to treatment assignment.

Results: Of the 237 patients enrolled, 206 met all entry criteria. The most common diagnoses were renal failure, nonhematologic cancer, and gastrointestinal disease. There was no statistically significant difference in outcome: of the 103 patients treated with amphotericin B, 81 (79 percent) were judged to have been treated successfully, as were 72 of the 103 patients treated with fluconazole (70 percent P = 0.22; 95 percent confidence interval for the difference, -5 to 23 percent). The bloodstream infection failed to clear in 12 patients in the amphotericin group and 15 in the fluconazole group; the species most commonly associated with failure was Candida albicans. There were 41 deaths in the amphotericin group and 34 deaths in the fluconazole group (P = 0.20). Intravascular catheters appeared to be the most frequent source of candidemia. There was less toxicity with fluconazole than with amphotericin B.

Conclusions: In patients without neutropenia and without major immunodeficiency, fluconazole and amphotericin B are not significantly different in their effectiveness in treating candidemia.

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Comment in

  • ACP J Club. 1995 Mar-Apr;122(2):42
  • The treatment of candidemia.
    DiNubile MJ. DiNubile MJ. N Engl J Med. 1995 Apr 20;332(16):1100-1; author reply 1101-2. N Engl J Med. 1995. PMID: 7898536 No abstract available.
  • The treatment of candidemia.
    Cofsky RD. Cofsky RD. N Engl J Med. 1995 Apr 20;332(16):1101; author reply 1101-2. N Engl J Med. 1995. PMID: 7898537 No abstract available.
  • The treatment of candidemia.
    Girmenia C, Martino P. Girmenia C, et al. N Engl J Med. 1995 Apr 20;332(16):1101; author reply 1101-2. N Engl J Med. 1995. PMID: 7898538 No abstract available.
  • The treatment of candidemia.
    Tang CM, Howe P, Crook DW. Tang CM, et al. N Engl J Med. 1995 Apr 20;332(16):1101; author reply 1101-2. N Engl J Med. 1995. PMID: 7898539 No abstract available.
  • Management of candidemia.
    Meunier F. Meunier F. N Engl J Med. 1994 Nov 17;331(20):1371-2. doi: 10.1056/NEJM199411173312011. N Engl J Med. 1994. PMID: 7935710 No abstract available.

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