Ketoconazole: clinical evaluation in severe fungal infections

Ketoconazole, a new imidazole-derivative antifungal agent, has been studied in sixteen patients with systemic fungal infections. Seven patients had deep localized infections (three cases with pneumonia and one case each with urinary infection, osteomyelitis, endophthalmitis and peritonitis); three patients suffered from granulomatous or acute mucocutaneous infections and six patients had fungal septicemia. All patients suffered from severe underlying diseases and/or predisposing factors such as antibiotic treatment, immunosuppressive therapy or indwelling catheters. Candida albicans was isolated in 13 cases, C. parapsilosis (septicemia), Aspergillus (ophthalmitis) and Mucor (pneumonia) in the other three cases. Ketoconazole was administered orally at daily dosages of 400-800 mg; 5-fluorocytosine was associated in four cases. Out of the ten patients with localized infections, seven were cured and three improved. Two of the six septic patients were cured, one improved who subsequently died from Pseudomonas septic shock and three patients showed no improvement. Two relapses were recorded, both followed by further eradication. The tolerance of the drug was always excellent. Ketoconazole proved a very effective and well-tolerated drug in systemic infections, caused by opportunistic fungi in high-risk patients.