Fluconazole treatment of children with severe fungal infections not treatable with conventional agents.

Fluconazole was evaluated prospectively in 173 children aged between 4 months and 16 years in whom conventional antifungal therapy was ineffective or contraindicated. Children entered the study on an individual compassionate request basis for treatment of confirmed or presumed fungal infection or for prophylaxis of fungal infections. Sixty-two children had cancer, 40 had undergone transplantation, 14 had AIDS and 52 had other conditions. The mean fluconazole dosage was 3.4 mg/kg/day (range 0.16-11.1 mg/kg/day) and the mean duration of therapy was 36 days (range 1-340 days). Efficacy was evaluated in 63 children with confirmed fungal infection as documented by the presence of a fungal pathogen at baseline; clinical cure or improvement was achieved in 83% (52/63), pathogen eradication in 73% (43/59). All 173 children were assessed for safety. Related or possibly related adverse events occurred in 6% (11/173) of patients; seven children were withdrawn from therapy because of adverse events. Results of this study demonstrate that the clinical efficacy and safety profile of fluconazole in the treatment of fungal infections in children are favorable, results being similar to those obtained in adults.