Fluconazole in the treatment of systemic candidiasis: an open-label, noncomparative, multinational study

Abstract

The incidence of opportunistic fungal infections has been increasing in recent years. Fluconazole has demonstrated significant clinical potential and is an attractive alternative to amphotericin B for the treatment of these infections. The present study investigated the efficacy and safety of fluconazole (100 to 400 mg/d) in severely ill patients with microbiologically documented systemic candidiasis. Of the 51 patients enrolled, 39 were assessable for efficacy. The predominant pathogen isolated was Candida albicans. At the end of treatment, clinical and mycologic response was 100%. At follow-up, one patient experienced a relapse caused by C albicans. The most common drug-related adverse events involved the gastrointestinal system (eg, diarrhea and vomiting); no patients withdrew from the study because of adverse events. Thus fluconazole appeared to be effective and safe in the treatment of systemic candidiasis.