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

Completed · Phase 1

Conditions studied: Candida

In brief

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

Key facts

Study ID

NCT00818584

Run by

Astellas Pharma Inc

People needed

13

Starts

2007-08-01

Expected to finish

2007-10-01

Last updated by the study team

2013-03-06

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Dallas, Texas, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Birmingham, Alabama, United States
• Study site — Orange, California, United States
• Study site — Louisville, Kentucky, United States
• Study site — Kansas City, Missouri, United States
• Study site — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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