High-Dose Micafungin in Neonates and Young Infants with Invasive Candidiasis: Results of a Phase 2 Study

Limited data are available on the most appropriate dosing, efficacy, and safety of micafungin in neonates and young infants with invasive candidiasis (IC). This study evaluated plasma levels, efficacy, and safety of micafungin at a dose of 8 mg/kg daily for a mean of 13.3 days (+/- 15.2 days) in 35 neonates and young infants with IC. Micafungin plasma concentrations were 5.70 mg/liter preadministration and 17.23, 15.59, and 10.27 mg/liter after 1, 2, and 8 h, respectively. The resolution of the infection was achieved in 86.7% of patients treated for >= 14 days. In 20.0% of patients, we observed a transient hypertransaminasemia. Micafungin at a dose of 8 mg/kg daily is effective and well tolerated in neonates and young infants with IC.

Automated summary

This study evaluated the efficacy and safety of micafungin at a dose of 8 mg/kg daily in 35 neonates and young infants with invasive candidiasis, showing that the treatment was effective in resolving the infection in 86.7% of patients treated for >= 14 days, with some patients experiencing transient hypertransaminasemia. Micafungin at this dosage was found to be well tolerated in this population.