An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
A Phase 1 Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates
1 other identifier
interventional
13
1 country
7
Brief Summary
This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2007
Shorter than P25 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 6, 2009
CompletedFirst Posted
Study publicly available on registry
January 7, 2009
CompletedMarch 6, 2013
March 1, 2013
2 months
January 6, 2009
March 4, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of micafungin plasma pharmacokinetic parameters
Day 4
Secondary Outcomes (1)
Monitor adverse events
11 or 12 Days
Study Arms (2)
1. micafungin lower dose
EXPERIMENTAL2. micafungin higher dose
EXPERIMENTALInterventions
IV Administration
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Birmingham, Alabama, 35233, United States
Unknown Facility
Orange, California, 92868, United States
Unknown Facility
Louisville, Kentucky, 40202, United States
Unknown Facility
Kansas City, Missouri, 64108, United States
Unknown Facility
Durham, North Carolina, 27710, United States
Unknown Facility
Dallas, Texas, 75390, United States
Unknown Facility
Charlottesville, Virginia, 22908, United States
Related Publications (1)
Benjamin DK Jr, Smith PB, Arrieta A, Castro L, Sanchez 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.
PMID: 19890251BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2009
First Posted
January 7, 2009
Study Start
August 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
March 6, 2013
Record last verified: 2013-03