A Randomized, Double-Blind, Prospective Study of Caspofungin vs. Amphotericin B for the Treatment of Invasive Candidiasis in Newborn Infants

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.