Overview

Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis

Status:
Completed
Trial end date:
2018-04-10
Target enrollment:
Participant gender:
Summary
The primary purpose of this study is to evaluate the pharmacokinetic profile of micafungin administered to neonates suffering from systemic candidiasis. This study will also evaluate the proportion of success and of failure of the therapy with micafungin among treated neonates and will identify a conversion factor to relate plasma levels of micafungin into capillary and venous blood measured through blood samples from the heel and from a peripheral vein, collected simultaneously. Safety of micafungin in neonates will also be assessed.
Phase:
Phase 2
Details
Lead Sponsor:
Astellas Pharma Global Development, Inc.
Collaborator:
IRCCS, Ospedale Pediatrico Bambino Gesu
Treatments:
Echinocandins
Micafungin