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
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 4.5 mg/kg (determined by the subject's weight at baseline). Serial blood samples for assessment of pharmacokinetics will be collected.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
9
IV
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Orange, California, United States
Unnamed facility
Louisville, Kentucky, United States
Unnamed facility
Kansas City, Missouri, United States
Evaluation of Micafungin pharmacokinetics
Time frame: 10 - 14 Days
Assess safety and tolerability of micafungin by adverse events, vital signs, hematology and chemistry laboratory tests, ECGs and physical evaluation
Time frame: Day 1 to End of Study
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Unnamed facility
Dallas, Texas, United States
Unnamed facility
Houston, Texas, United States