The PTN team behind the Safety of Fluconazole Prophylaxis in Infants study successfully locked the Benjamin study database last week. To evaluate the safety of fluconazole, the team is gathering randomized trial datasets from several thought leaders to perform a data meta-analysis—the Benjamin study comprises the first of these datasets. The PTN will examine safety data from these earlier randomized controlled trials of fluconazole prophylaxis to prevent candidiasis in very low birth weight and extremely low birth weight infants. Infants born <28 weeks gestational age are susceptible to this disease, which can lead to death or neurodevelopmental impairment.
The Benjamin study was a phase 3, randomized, blinded, multicenter, placebo-controlled trial comparing the efficacy of fluconazole administration to placebo for the prevention of neonatal candidiasis in infants <750 grams birth weight. The primary purpose of the trial was to evaluate death or candidiasis at study day 49 and to determine the safety and efficacy of fluconazole in this context.
The PTN team will analyze this and the other datasets to study primary safety outcomes, including gastrointestinal events, adverse events, serious adverse events, and laboratory values. By cultivating a better understanding of the potential safety issues involved with treating low birth weight infants with fluconazole, we hope to use the drug to better prevent the devastating results of candidiasis in this vulnerable population.