Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug
Completed · Phase 1
Conditions studied: Oropharyngeal Candidiasis, Candidemia, Invasive Candidiasis, Esophageal Candidiasis
In brief
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 children weighing \> 25 kg.
Key facts
- Study ID
- NCT00608335
- Run by
- Astellas Pharma Inc
- People needed
- 84
- Starts
- 2007-10-14
- Expected to finish
- 2011-09-08
- Last updated by the study team
- 2024-11-18
Who can join
Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
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
Where it is running
- University of California Los Angeles Medical Center — Los Angeles, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Oregon Health and Science University — Portland, Oregon, United States
- University of Texas Southwestern — Dallas, Texas, United States
- Texas Children's Hospital — Houston, Texas, United States
- Benmed Park Clinic — Benoni, South Africa
- Grootte Schuur Hospital — Cape Town, South Africa
- GCT -Sunnyside Medi-clinic — Lynn East, South Africa
- St. Mary's Hospital — Mariannhill, South Africa
- Jubilee Hospital — Themba, South Africa
- 2 Military Hospital — Wynberg, South Africa
Full record on ClinicalTrials.gov
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