Prevention of severe Candida infections in nonneutropenic, high-risk, critically ill patients: a randomized, double-blind, placebo-controlled trial in patients treated by selective digestive decontamination

Intensive Care Med. 2002 Dec;28(12):1708-17. doi: 10.1007/s00134-002-1540-y. Epub 2002 Nov 1.


Objective: Infections caused by Candida spp. are a major cause of morbidity and mortality in critically ill patients and usually develop from endogenous colonization. We assessed the effectiveness of adding fluconazole to a selective digestive decontamination regimen to prevent candidal infections.

Design and setting: We performed a prospective, randomized, double-blind, placebo-controlled trial among medical and surgical intensive care unit patients at a large university hospital.

Patients: All adult patients mechanically ventilated for at least 48 h with an expectation to remain so for at least an additional 72 h, and receiving selective decontamination of the digestive tract.

Interventions: Patients were randomly assigned fluconazole 100 mg daily (n=103) or placebo (n=101).

Measurements and results: Candida infections occurred less frequently in the fluconazole group (5.8%) than in the placebo group (16%; rate ratio 0.35; Cl(95) 0.11-0.94). Some 90% of candidemia episodes occurred in the placebo group (rate ratio for fluconazole use 0.10; Cl(95) 0.02-0.74). The rate of treatment failure, development of candidal infection, or increased colonization, was 32% in the fluconazole group and 67% in the placebo group (P<0.001). Crude in-hospital mortality was similar in the two groups (39% fluconazole vs. 41% placebo).

Conclusions: Prophylactic use of fluconazole in a selected group of mechanically ventilated patients at high risk for infection reduces the incidence of Candida infections, in particular candidemia.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibiotic Prophylaxis
  • Antifungal Agents / therapeutic use*
  • Candidiasis / microbiology
  • Candidiasis / prevention & control*
  • Chi-Square Distribution
  • Critical Illness*
  • Decontamination / methods
  • Digestive System / microbiology
  • Double-Blind Method
  • Female
  • Fluconazole / therapeutic use*
  • Humans
  • Intensive Care Units
  • Male
  • Neomycin / therapeutic use
  • Polymyxins / therapeutic use
  • Prospective Studies
  • Risk Factors
  • Statistics, Nonparametric
  • Survival Analysis
  • Treatment Outcome
  • Vancomycin / therapeutic use


  • Antifungal Agents
  • Polymyxins
  • Vancomycin
  • Fluconazole
  • Neomycin