Study Completion in Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Pediatric Subjects with BMI ≥85th Percentile

Study Completion data
Study Description
The primary objective of CLN01 was to determine the pharmacokinetics (PK) of intravenous (IV) clindamycin in overweight and obese children and adolescents. This study was a prospective, open-label safety and PK study of multiple doses of IV and oral clindamycin in overweight and obese children 2 to <18 years of age. Clindamycin PK samples to develop the population PK model were also collected from NICHD-2011-POP01 and NICHD-2012-STA01 and analyzed as part of CLN01. Overall, clindamycin was very well tolerated in this open-label study. Three AEs (including one SAE) were reported in 2 (9%) CLN01 patients; none were considered related to study drug. After accounting for size-based differences using total body weight and physiologic differences using age, only volume of distribution and terminal elimination half-life were significantly different between obese and non-obese children. Clindamycin may be dosed based on total body weight (max dose 2.7 g/day) without dose adjustment based solely on obesity. Children 2 years to <18 years of age at the time of first dose of study drug, with either suspected or confirmed infection or receiving IV clindamycin per routine care, and BMI ≥ 85th percentile for age and sex based on CDC recommendations