Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis

A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis

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.

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

Inclusion Criteria:

• Infant greater than 48 hours of life after birth up to day of life 120 at the time of culture acquisition
• Diagnosis of proven invasive candidiasis within 4 days prior to study start
• Subject's parent or legal guardian agrees not to allow subject to participate in another study with another investigational drug while on treatment.

Exclusion Criteria:

• Infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or systemic amphotericin B product
• Infant who has received more than 48 hours of systemic antifungal therapy prior to the first dose of study drug
• Infant who has a breakthrough systemic fungal infection while receiving amphotericin B product or an echinocandin as prophylaxis
• Infant who has failed prior systemic antifungal therapy for this episode of invasive candidiasis
• Infant who is co-infected with a non-Candida fungal organism
• Infant whose positive yeast cultures are solely from an indwelling bladder catheter (unless obtained at the time the indwelling catheter was placed) or sputum.
• Infant previously enrolled in this study