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 with invasive candidiasis (IC). This study evaluated plasma levels, efficacy and safety of micafungin at a dose of 8 mg/kg/day for a mean of 13·3 (± 5·2) days in 35 neonates and young infants with IC. Micafungin plasma concentrations were 5·70 mg/L pre-administration and 17·23, 15·59 and 10·27 mg/L after 1, 2, and 8 hours, respectively. The resolution of the infection was achieved in 86·7% of patients treated 14 or more days. In 20·0% of patients we observed a transient hyper-transaminasemia. Micafungin at a dose of 8 mg/kg/day is effective and well tolerated in neonates and young infants with IC.