An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

Subjects will be stratified by weight to receive one of two doses of study drug

Inclusion Criteria:

• Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
• Infant has sufficient venous access to permit study drug dosing
• Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry

Exclusion Criteria:

• Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
• Infant has received an echinocandin within one month prior to study entry
• Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
• Infant has a life expectancy of less than 96 hours