The study will evaluate PK and safety of two dose levels of Micafungin (FK463) as Antifungal prophylaxis in children and adolescents undergoing HSCT
This is a prospective, multi-center, open-label, repeat-dose pharmacokinetic study that contains two treatment (micafungin 1.0mg/kg and 1.5mg/kg) dose groups. Subjects will be enrolled according to age and stratified by weight to receive either 1.0mg/kg (weight \> 25kg) or 1.5mg/kg ( weight \< 25kg) micafungin. Children (4 months to \< 2years, 2 to 5 years and 6 to 11 years) and adolescents (12 to 16 years) undergoing HSCT who require antifungal prophylaxis will be enrolled
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
42
IV
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Palo Alto, California, United States
Unnamed facility
Plasma drug concentration parameters: AUC0-24, Cmax
Time frame: 13-17 Days
Adverse events, vital signs, ECGs and laboratory test values
Time frame: Day 1 to End of study
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Denver, Colorado, United States
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Indianapolis, Indiana, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Rochester, New York, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Memphis, Tennessee, United States
...and 2 more locations