Large-scale multicentre study of fluconazole in the treatment of hospitalised patients with fungal infections. Multicentre European Study Group.

The purpose of this prospective, open-label, noncomparative, multicentre study was to evaluate the efficacy and safety of fluconazole in the treatment of hospitalised patients with mycoses. A total of 587 patients with diagnosed fungal infections were enrolled. Fluconazole was given orally or intravenously in a 200 or 400 mg loading dose, followed by 100 or 200 mg once daily. The most common candidal infections were fungemia, esophageal candidiasis, bronchopulmonary candidiasis, peritonitis, oropharyngeal candidiasis, urinary tract infection and deep wound infection. Meningitis was the most common cryptococcal infection. Of the 291 evaluable patients with candidiasis, 96% (70/73) of AIDS patients and 79% (171/218) of non-AIDS patients were clinically cured or improved. Of the 36 evaluable patients with cryptococcosis, 69% (20/29) of AIDS patients and 100% (7/7) of non-AIDS patients responded clinically. The overall mycological eradication rate was 85%; eradication was similar in patients with and without AIDS. Most adverse events during fluconazole therapy were mild to moderate in severity. This investigation confirms the results of previous studies demonstrating high response rates to fluconazole therapy in AIDS and non-AIDS patients with fungal infections. Even during long-term therapy treatment-limiting adverse events were uncommon with fluconazole.