Fluconazole in the prophylaxis of fungal infection after bone marrow transplantation

An open, non-comparative study was conducted to investigate the efficacy and safety of fluconazole in the prophylaxis of superficial or systemic fungal infections in patients having received bone marrow transplantation (BMT). The study population consisted of a total of 53 patients, including 10 children between the ages of 3 and 14 years who were scheduled for BMT. Fluconazole prophylaxis was initiated at 200 mg day(-1) in adults and 100 mg day(-1) in children. It was started at a mean of 7 days before treatment and continued for up to 112 days in the paediatric patients and 393 days in the adult patients. Apart from the baseline examination and the final evaluation, the patients were evaluated mycologically and serologically for the presence of fungal infections on a weekly basis, if feasible. Proven fungal infection, oesophageal candidosis or oropharyngeal candidosis was not found in any of the patients under study during the fluconazole prophylaxis. Thirteen of the adult patients developed unexplained fevers and had their treatment supplemented by antibiotic therapy and treatment with amphotericin B. In all 10 children, the prophylactic treatment proved successful. Adverse events were seen in 15 patients. In one case only, the event was judged to be causally related or possibly causally related to the study drug. Hence, fluconazole proves to be an effective and well-tolerated agent in the prophylaxis of fungal infections in recipients of bone marrow transplants.