Conditions: Candidiasis
Keywords: candidiasis candida Neonate candidemia Micafungin Mycamine amphotericin B deoxycholate
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30
Healthy volunteers: no

Brief summary:
The study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin B deoxycholate in treating neonates and young infants with certain fungal infections.

Detailed description:
Neonates and young infants will be stratified by estimated gestational age and by world region

Arms:
arm 1: Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination. arm 2: Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.

Interventions: intervention 1: micafungin intervention 2: amphotericin B deoxycholate
Intervention descriptions: intervention 1: Administered by intravenous infusion intervention 2: Administered by intravenous infusion

Protocol document: