Status:
COMPLETED
Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Lead Sponsor:
Astellas Pharma Inc
Conditions:
Oropharyngeal Candidiasis
Candidemia
Eligibility:
All Genders
2-16 years
Phase:
PHASE1
Brief Summary
Children with fungal infections will be divided into two groups by weight. Children weighing \< 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than childre...
Detailed Description
This is a prospective, multicenter, open-label, repeat-dose study conducted in two groups. Subjects in Group 1 and Group 2 will receive treatment for 10 to 14 days (per investigator clinical judgment)...
Eligibility Criteria
Inclusion
- Subject is 2 to 16 years inclusive
- 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 14 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00608335
Start Date
October 14 2007
End Date
September 8 2011
Last Update
November 18 2024
Active Locations (13)
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1
University of California Los Angeles Medical Center
Los Angeles, California, United States, 90095
2
Children's Hospital of Orange County
Orange, California, United States, 92868
3
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
4
Duke University Medical Center
Durham, North Carolina, United States, 27710