An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candida
Intervention: Micafungin (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Director, Affiliation: Astellas Pharma US, Inc.
Summary
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates
with suspected candida infection
Clinical Details
Official title: A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Assessment of micafungin plasma pharmacokinetic parameters
Secondary outcome: Monitor adverse events
Detailed description:
Subjects will be stratified by weight to receive one of two doses of study drug
Eligibility
Minimum age: N/A.
Maximum age: 120 Days.
Gender(s): Both.
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
Locations and Contacts
Birmingham, Alabama 35233, United States
Orange, California 92868, United States
Louisville, Kentucky 40202, United States
Kansas City, Missouri 64108, United States
Durham, North Carolina 27710, United States
Dallas, Texas 75390, United States
Charlottesville, Virginia 22908, United States
Additional Information
Link to results on JAPIC
Related publications: Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sánchez PJ, Kaufman D, Arnold LJ, Kovanda LL, Sawamoto T, Buell DN, Hope WW, Walsh TJ. Safety and pharmacokinetics of repeat-dose micafungin in young infants. Clin Pharmacol Ther. 2010 Jan;87(1):93-9. doi: 10.1038/clpt.2009.200. Epub 2009 Nov 4.
Starting date: August 2007
Last updated: March 4, 2013
|
