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

Abstract

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 (±5.2 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. (This study has been registered at ClinicalTrials.gov under identifier NCT03421002 and in the EU Clinical Trials Register under number 2014-003087-20.).

Keywords: echinocandins; invasive candidiasis; micafungin; neonatal intensive care unit.

Copyright © 2021 American Society for Microbiology.

Figures

FIG 1

Plasma concentrations of micafungin measured in heel-stick capillary samples from 34 patients. Safety analysis set comprised all enrolled patients who had received at least one dose of study drug. One patient died before the complete pharmacokinetic draw could take place. SD, standard deviation.