Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Infants And Toddlers (≥4 Months TO < 24 Months Of Age) With Esophageal Candidiasis Or Other Invasive Candidiasis
1 other identifier
interventional
9
1 country
6
Brief Summary
Infants and toddlers with fungal infections will receive 10 to 14 days of treatment with an antifungal drug. Safety and drug blood levels will be assessed
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 Oct 2007
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedAugust 20, 2014
August 1, 2014
2 years
January 23, 2008
August 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of Micafungin pharmacokinetics
10 - 14 Days
Secondary Outcomes (1)
Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation
Day 1 to End of Study
Study Arms (1)
1. Micafungin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject is ≥4 months to \< 24 months
- Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
- Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables
You may not qualify if:
- Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase \> 5 times the upper limit of normal (ULN)
- Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
- Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
- Subject has received treatment with an echinocandin within one week prior to first dosing
- Subject status is unstable and subject is unlikely to complete all study required procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Unknown Facility
Los Angeles, California, 90095, 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
Dallas, Texas, 75390, United States
Unknown Facility
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Central Contact
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
October 1, 2007
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
August 20, 2014
Record last verified: 2014-08