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

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