Pharmacokinetics and safety of fluconazole and micafungin in neonates with systemic candidiasis: a randomized, open-label clinical trial.

ABSTRACT:

Aims

The pharmacokinetics (PK) of fluconazole and micafungin differ in neonates compared with children and adults. Dosing instructions in product labels appear to be inconsistent with the emerging scientific evidence. Limited information is available on the safety profile of these agents in neonates. Our objective was to study the population PK and safety of both drugs, randomly administered in neonates with suspected or confirmed systemic candidiasis.

Methods

Neonates were randomized 1:1 to fluconazole (loading dose 25 mg kg^-1 ; maintenance dose 12 mg kg^-1 day^-1 or 20 mg kg^-1 day^-1 , respectively, for infants <30 weeks or ≥30 weeks' corrected gestational age) or micafungin (loading dose 15 mg kg^-1 day^-1<

SUBMITTER: Leroux S 

PROVIDER: S-EPMC6089805 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature