An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
- Registration Number
- NCT00818584
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
- Detailed Description
Subjects will be stratified by weight to receive one of two doses of study drug
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1. micafungin lower dose Micafungin - 2. micafungin higher dose Micafungin -
- Primary Outcome Measures
Name Time Method Assessment of micafungin plasma pharmacokinetic parameters Day 4
- Secondary Outcome Measures
Name Time Method Monitor adverse events 11 or 12 Days