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

Cinzia Auriti1, Bianca M Goffredo2, Maria P Ronchetti3

  • 1Neonatal Intensive Care Unit, Bambino Gesù Children's Hospital, Rome, Italy cinzia.auriti@opbg.net.

Antimicrobial Agents and Chemotherapy
|February 9, 2021
PubMed

Insights

Micafungin at 8 mg/kg daily effectively treats invasive candidiasis in neonates and infants. This antifungal medication demonstrated good tolerability and achieved high infection resolution rates in the study population.

Area of Science:

  • Pediatric Infectious Diseases
  • Pharmacology and Therapeutics
  • Neonatal Medicine

Background:

  • Limited data exist on micafungin dosing, efficacy, and safety in neonates and young infants with invasive candidiasis (IC).
  • Establishing optimal treatment protocols for IC in this vulnerable population is crucial.

Purpose of the Study:

  • To evaluate the plasma levels, efficacy, and safety of micafungin in neonates and young infants diagnosed with invasive candidiasis.
  • To determine the pharmacokinetic profile and clinical outcomes associated with a specific micafungin dosage.

Main Methods:

  • A study involving 35 neonates and young infants with IC.
  • Micafungin administered at a dose of 8 mg/kg daily for a mean duration of 13.3 days.
  • Measurement of micafungin plasma concentrations at various time points post-administration.

Main Results:

  • Micafungin plasma concentrations were observed pre-administration and at 1, 2, and 8 hours post-administration.
  • Infection resolution was achieved in 86.7% of patients treated for ≥14 days.
  • Transient hypertransaminasemia was noted in 20.0% of patients, indicating good overall tolerability.

Conclusions:

  • Micafungin at a dose of 8 mg/kg daily is an effective and well-tolerated treatment option for invasive candidiasis in neonates and young infants.
  • The study supports the use of this regimen for managing IC in this specific patient group.
Keywords:
echinocandinsinvasive candidiasismicafunginneonatal intensive care unit

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