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

• Status: Terminated
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Deoxycholic Acid; Echinocandins; Liposomal amphotericin B; Micafungin

Criteria

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