Status:
COMPLETED
Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Invasive Candidiasis
Esophageal Candidiasis
Eligibility:
All Genders
4-23 years
Phase:
PHASE1
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
Detailed Description
This is a prospective, multicenter, open-label, repeat-dose study. Subjects will receive treatment with intravenous micafungin for 10 to 14 days (per investigator clinical judgment) at a daily dose of...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00607763
Start Date
October 1 2007
End Date
October 1 2009
Last Update
August 20 2014
Active Locations (6)
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1
Los Angeles, California, United States, 90095
2
Orange, California, United States, 92868
3
Louisville, Kentucky, United States, 40202
4
Kansas City, Missouri, United States, 64108