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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
84
IV
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
PK parameters (AUCtau, Tmax, and Cmax)
Time frame: 10 - 14 Days
Adverse events
Time frame: Day 1 to End of Study
Vital signs
Time frame: Day 1 to End of Study
Hematology and chemistry laboratory tests
Time frame: Day 1 to End of Study
12-lead ECGs and Physical examination
Time frame: Day 1 to End of Study
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