Controlled study of fluconazole in the prevention of fungal infections in neutropenic patients with haematological malignancies and bone marrow transplant recipients

  • M. E. Ellis
  • H. Clink
  • P. Ernst
  • M. A. Halim
  • A. Padmos
  • D. Spence
  • M. Kalin
  • S. M. Hussain Qadri
  • J. Burnie
  • W. Greer
Article

DOI: 10.1007/BF02026116

Cite this article as:
Ellis, M.E., Clink, H., Ernst, P. et al. Eur. J. Clin. Microbiol. Infect. Dis. (1994) 13: 3. doi:10.1007/BF02026116

Abstract

The efficacy and safety of oral fluconazole versus a polyene regimen in preventing mycoses in neutropenic patients was compared. Patients with haematological malignancy or bone marrow transplantation received as antifungal prophylaxis either fluconazole 200 mg daily or a regimen consisting of clotrimazole trouches 10 mg twice daily with mycostatin, 500,000 i.u. four times daily, benadryl and cepacol mouthwash. Ninety patients at risk for fungus infection were evaluable. Four of 42 patients (9.5 %; confidence interval 2 %–23 %) on fluconazole and 17 of 48 patients (35.4 %; confidence interval 22 %–52 %) (p<0.01) on the clotrimazole regimen developed a clinically significant fungal infection, including 3 (7.1 %) and 11 (22.9 %) patients respectively who had severe fungal infection, mainly pulmonary aspergillosis. Death directly due to a fungal infection within 100 days of the start of prophylaxis occurred in 2 of 42 patients (4.8 %) and 9 of 48 patients (18.8 %) respectively (p<0.06). Kaplan-Meier analysis showed that the chance of survival on fluconazole was statistically greater than for the clotrimazole regimen (p<0.04). A decrease of candidal colonisation of the gastrointestinal and genitourinary tracts occurred only in patients receiving fluconazole. No significant toxicity occurred. A 200 mg daily dose of fluconazole given to these patients thus appears to be well tolerated and to provide a protective effect against the development of fungal infection and death from severe fungal disease.

Copyright information

© Friedr. Vieweg & Sohn Verlagsgesellschaft mbH 1994

Authors and Affiliations

  • M. E. Ellis
    • 1
  • H. Clink
    • 2
  • P. Ernst
    • 2
  • M. A. Halim
    • 1
  • A. Padmos
    • 2
  • D. Spence
    • 2
  • M. Kalin
    • 5
  • S. M. Hussain Qadri
    • 3
  • J. Burnie
    • 6
  • W. Greer
    • 4
  1. 1.Department of MedicineKing Faisal Specialist Hospital and Research CentreRiyadhKingdom of Saudi Arabia
  2. 2.Department of OncologyKing Faisal Specialist Hospital and Research CentreRiyadhKingdom of Saudi Arabia
  3. 3.Department of Pathology and Laboratory MedicineKing Faisal Specialist Hospital and Research CentreRiyadhKingdom of Saudi Arabia
  4. 4.Biomedical Statistics and Scientific Computing DepartmentKing Faisal Specialist Hospital and Research CentreRiyadhKingdom of Saudi Arabia
  5. 5.Karolinska HospitalStockholmSweden
  6. 6.University of Manchester Medical SchoolManchesterUK

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