Status:
COMPLETED
An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Candida
Eligibility:
All Genders
48-120 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00818584
Start Date
August 1 2007
End Date
October 1 2007
Last Update
March 6 2013
Active Locations (7)
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1
Birmingham, Alabama, United States, 35233
2
Orange, California, United States, 92868
3
Louisville, Kentucky, United States, 40202
4
Kansas City, Missouri, United States, 64108