An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
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Ages Eligible for Study:
up to 120 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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