PTN study of clindamycin dosing in obese children enrolls first patients

The University of Louisville in Kentucky and Children’s Mercy Hospital of Kansas City, Missouri, have enrolled the first two patients into the PTN study of the safety and pharmacokinetics of clindamycin in obese children. Principal investigators Michael Smith, MD, (Louisville) and Jen Goldman, MD, (Children’s Mercy) both enrolled their participants on August 8, marking the start of this trial to determine optimal dosing of the drug in young people with a body mass index ≥85th percentile for age.

Clindamycin is considered a first-line therapy for the treatment of methicillin-resistant Staphylococcus aureus (MRSA), an infection that often occurs in obese patients. Because excess weight results in altered body composition, physiology, and resulting changes in drug distribution, dosing guidelines based on normal weight adults cannot be extrapolated to their overweight and obese counterparts, and especially not to obese children.

Rates of childhood obesity have risen over the past decade, thus making it critical that safety and efficacy studies of drugs used in kids and adolescents be conducted to ensure effective treatment. The PTN clindamycin study will help to fill this knowledge gap; initial results are anticipated in mid 2014.