CONTROLLED-STUDY OF FLUCONAZOLE IN THE PREVENTION OF FUNGAL-INFECTIONS IN NEUTROPENIC PATIENTS WITH HEMATOLOGICAL MALIGNANCIES AND BONE-MARROW TRANSPLANT RECIPIENTS

The efficacy and safety of oral fluconazole versus a polyene regimen i n preventing mycoses in neutropenic patients was compared. Patients wi th haematological malignancy or bone marrow transplantation received a s 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 pati ents (9.5 %; confidence interval 2 %-23 %) on fluconazole and 17 of 48 patients (35.4 %; confidence interval 22 %-52 %) (p < 0.01) on the cl otrimazole regimen developed a clinically significant fungal infection , including 3 (7.1 %) and 11 (22.9 %) patients respectively who had se vere 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 %) res pectively (p < 0.06). Kaplan-Meier analysis showed that the chance of survival on fluconazole was statistically greater than for the clotrim azole regimen (p < 0.04). A decrease of candidal colonisation of the g astrointestinal and genitourinary tracts occurred only in patients rec eiving fluconazole. No significant toxicity occurred. A 200 mg daily d ose of fluconazole given to these patients thus appears to be well tol erated and to provide a protective effect against the development of f ungal infection and death from severe fungal disease.