Candidemia Clinical Trial
Official title:
A Phase 1, Open-Label Study Of The Safety And Pharmacokinetics Of Repeated-Dose Micafungin (FK463) In Children (2-5 Years AND 6-11 Years) And Adolescents (12-16 Years) With Esophageal Candidiasis Or Other Invasive Candidiasis
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.
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); dose level (3.0 mg/kg or 4.5 mg/kg) will be determined by the subject's
weight at baseline. Study procedures in both groups will be similar except that serial blood
samples for assessment of pharmacokinetics will be collected in Group 1. Subjects may only
participate in one group of the study.
At least 24 subjects, with at least 8 in each of three age ranges, will be enrolled in Group
1 (PK + safety). At least 36 subjects will be enrolled in Group 2 (safety), with at least 12
in each of the three age ranges.
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