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

• Status: Completed
• Trial end date: 2007-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Echinocandins; Micafungin

Criteria

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