Fluconazole treatment of neonates and infants with severe fungal infections not treatable with conventional agents.

Fluconazole was evaluated prospectively in 40 neonates and infants between the ages of 2 days and 3 months in whom conventional antifungal therapy was ineffective or contraindicated. The patients received therapy on an individual compassionate request basis for microbiologically documented or presumed fungal infection. The mean fluconazole dosage was 5.3 mg/kg/day (range 1-16 mg/kg/day) and the mean duration of therapy was 26 days (range 2-80 days). Efficacy was evaluated in neonates with proven fungal infection as documented by the presence of a pathogen at baseline. A positive clinical response was achieved in 97% (31/32) of the clinically evaluable patients; eradication of the fungal organism was achieved in 97% (30/31) of evaluable patients. Adverse events occurred in two patients (5%); therapy was not discontinued in either patient. These favorable safety and efficacy data are similar to results obtained with fluconazole in older children and adults.