Safety and Pharmacokinetics of Multiple-Dose Intravenous and Oral Clindamycin in Obese Children

Evaluating the safety and pharmacokinetics of clindamycin, an antibiotic commonly used to treat MRSA infections, in children and adolescents who are overweight or obese.

Summary

This study seeks to determine the pharmacokinetics (PK) of intravenous and oral clindamycin in overweight and obese children and adolescents. Up to 32 children and adolescents ages 2 to <18 years with a body mass index (BMI) ≥85th percentile for age will be enrolled to receive multiple doses of clindamycin over a maximum treatment period of 14 days.

http://vimeo.com/68245579

Community-acquired methicillin-resistant Staphylococcus aureus (MRSA) has become a leading cause of hospitalization among children and adolescents in the United States. Antimicrobial agents, such as clindamycin, have emerged as first-line therapies for the treatment of this disease: the use of clindamycin among children hospitalized with MRSA increased from 21% in 1999 to 63% in 2008.

In recent decades, rates of childhood obesity have also continued to rise. National data estimate that as many a 17% of children aged 2–19 years in the United States are obese (defined as a BMI ≥95th percentile), and 12.3% are morbidly obese (BMI ≥97th percentile). Unfortunately, obese patients are at increased risk of developing Staphylococcus aureus infections and have a greater likelihood of developing complications from such infections.

Typical clindamycin dosing guidelines based on patient weight may not be appropriate for obese children because of altered body composition, physiology, and resulting changes in drug distribution. Notably, variability in serum and tissue concentrations has been reported in obese adults. This study will determine the PK of intravenous and oral clindamycin in obese pediatric patients and characterize the safety profile of clindamycin in overweight and obese children and adolescents.

Publications

Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants
Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK, Laughon MM, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network Steering Committee.
Antimicrobial Agents and Chemotherapy• February 29, 2016 (E-Pub ahead of print).
PubMed ID (PMID): 26926644.

Presentations

Pediatric Academic Societies Annual Meeting, April 25-28, 2015

Pharmacokinetics of Multiple-Dose Intravenous Clindamycin in Obese Children
Smith MJ, Gonzalez D, Goldman JL, Yogev R, Sullivan JE, Reed MD, Anand R, Martz K, Berezny KY, Smith PB, Cohen-Wolkowiez M, Watt K, on behalf of the Best Pharmaceuticals for Children Act – Pediatric Trials Network

 

OVERVIEW

Status:
Clinical study report submitted to FDA

ClinicalTrials.gov identifier:
NCT01744730

Principal Investigators:
P. Brian Smith, MD, MPH, MHS
Duke Health, Durham, NC

Michael J. Smith, MD, MSCE
University of Louisville, Louisville, KY

NEWS

  • PTN study of clindamycin dosing in obese children enrolls first patients August 20, 2013 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 ...