Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2001 Apr;233(4):542-8.
doi: 10.1097/00000658-200104000-00010.

Double-blind placebo-controlled trial of fluconazole to prevent candidal infections in critically ill surgical patients

R K Pelz  1 , C W Hendrix, S M Swoboda, M Diener-West, W G Merz, J Hammond, P A Lipsett
Affiliations
Clinical Trial

Double-blind placebo-controlled trial of fluconazole to prevent candidal infections in critically ill surgical patients

R K Pelz et al. Ann Surg. 2001 Apr.

Abstract

Objective: To evaluate the prophylactic use of enteral fluconazole to prevent invasive candidal infections in critically ill surgical patients.

Summary background data: Invasive fungal infections are increasingly common in the critically ill, especially in surgical patients. Although fungal prophylaxis has been proven effective in certain high-risk patients such as bone marrow transplant patients, few studies have focused on surgical patients and prevention of fungal infection.

Methods: The authors conducted a prospective, randomized, placebo-controlled trial in a single-center, tertiary care surgical intensive care unit (ICU). A total of 260 critically ill surgical patients with a length of ICU stay of at least 3 days were randomly assigned to receive either enteral fluconazole 400 mg or placebo per day during their stay in the surgical ICU at Johns Hopkins Hospital.

Results: The primary end point was the time to occurrence of fungal infection during the surgical ICU stay, with planned secondary analysis of patients "on-therapy" and alternate definitions of fungal infections. In a time-to-event analysis, the risk of candidal infection in patients receiving fluconazole was significantly less than the risk in patients receiving placebo. After adjusting for potentially confounding effects of the Acute Physiology and Chronic Health Evaluation (APACHE) III score, days to first dose, and fungal colonization at enrollment, the risk of fungal infection was reduced by 55% in the fluconazole group. No difference in death rate was observed between patients receiving fluconazole and those receiving placebo.

Conclusions: Enteral fluconazole safely and effectively decreased the incidence of fungal infections in high-risk, critically ill surgical patients.

PubMed Disclaimer

Figures

None
Figure 1. Enrollment of study cohort.
None
Figure 2. Kaplan-Meier curves showing time to proven infection, intent-to-treat analysis.
See this image and copyright information in PMC

References

    1. Jarvis WR. Epidemiology of nosocomial fungal infections, with emphasis on Candida species. Clin Infect Dis 1995; 20: 1526–1530. - PubMed
    1. Wey SB, Mori M, Pfaller MA, et al. Risk factors for hospital-acquired candidemia. Arch Intern Med 1989; 149: 2349–2353. - PubMed
    1. Karabinis A, Hill C, Leclerq B, et al. Risk factors for candidemia in cancer patients: a case-control study. J Clin Microbiol 1988; 26: 429–432. - PMC - PubMed
    1. Bross J, Talbot GH, Maislin G, et al. Risk factors for nosocomial candidemia: a case-control study. Am J Med 1989; : 614–620. - PubMed
    1. Komshian SV, Uwaydah A, Sobel JD, et al. Fungemia caused by Candida species and Torulopsis glabrata in the hospitalized patient: frequency, characteristics, and evaluation of factors influencing outcome. Rev Infect Dis 1989; 11: 379–390. - PubMed

Publication types