Red Book updated with fluconazole dosing information from PTN study

The American Academy of Pediatrics (AAP) has updated the 2018 edition of the Red Book to include fluconazole dosing information determined by a Pediatric Trials Network (PTN) study. The Red Book is the leading resource on pediatric infectious disease, providing the most up-to-date information on a wide variety of diseases that doctors see in children.

The updates include dosing information for the treatment of Cryptococcus neoformans and Cryptococcus gattii infections, as well as Cryptococcal meningitis in children. The updates, which can be viewed on Red Book Online, will enable doctors to provide a safer, more accurate dose of the antifungal drug fluconazole to treat these diseases in children.

The changes were based on a study conducted from 2008 to 2011 in collaboration with PTN that analyzed safety data on the use of fluconazole to treat infections caused by the Candida yeast. While Candida and Cryptococcus yeasts are not the same, they are treated similarly enough to allow dosing information for one to apply to the other. The study examined data from nearly 800 infants in three randomized trials.

The research was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

The fluconazole prophylaxis study locks its database

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.