Dataset from Fluconazole Prophylaxis for the Prevention of Candidiasis in Infants <750 Grams Birth Weight

This was a prospective, randomized, double-blind, multi-center, efficacy study comparing fluconazole prophylaxis to placebo. The study objective was to determine the safety and efficacy of fluconazole for the prevention of candidiasis in infants <750 grams birth weight. The primary endpoint was death or candidiasis prior to study day 49. The prophylaxis trial observed gastrointestinal safety signals that have not been previously reported for fluconazole. Based on this observation additional information was obtained from the subjects enrolled in the prophylaxis trial. The fluconazole safety study analyzed the data to better evaluate these safety signals.