Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis (MAGIC-2)

Astellas

Status and phase: Terminated; Phase 3

Conditions: Candidiasis

Treatments: Drug: amphotericin B deoxycholate; Drug: micafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00815516

2012-000780-24 (EudraCT Number)

9463-CL-2303

Details and patient eligibility

About

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.

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 48 hours to 120 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Micafungin

Experimental group

Description:

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.

Treatment:

Drug: micafungin

Amphotericin B deoxycholate

Active Comparator group

Description:

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.

Treatment:

Drug: amphotericin B deoxycholate