A randomized, double-blind, prospective study of caspofungin vs. amphotericin B for the treatment of invasive candidiasis in newborn infants.

BACKGROUND Caspofungin is an echinocandin agent with fungicidal activity against Candida species. OBJECTIVE To assess the efficacy, safety and tolerability of caspofungin relative to amphotericin B in neonates with invasive candidiasis. PATIENTS AND METHODS Thirty-two neonates with invasive candidiasis were randomly assigned to receive either caspofungin (n = 15) or amphotericin B (n = 17). Efficacy was evaluated, with a successful outcome defined as fulfilling all the components of a prespecified five-part composite endpoint. Evaluation of safety was done by monitoring drug-related adverse events. RESULTS At the end of intravenous therapy, evaluation showed that caspofungin was superior, with a favorable response in 86.7% of patients as compared with 41.7% of those who received amphotericin B (p = 0.04). There were significantly fewer adverse events in the caspofungin group than in the amphotericin B group. CONCLUSION Caspofungin is more effective, safer and alternative to amphotericin B for the treatment of invasive candidiasis in newborn infants.