Pharmacokinetics of Trimethoprim-Sulfamethoxazole and Clindamycin

Assessing the safety and pharmacokinetics of trimethoprim-sulfamethoxazole and clindamycin, antibiotics for the treatment of skin and soft tissue infections, in children by analyzing data from completed studies.


Despite the common use of trimethoprim-sulfamethoxazole and clindamycin in children for the treatment of skin and soft tissue infections, there is a lack of pharmacokinetics (PK) and safety studies to adequately define optimal dosing. Challenges associated with pediatric clinical trials limit the ability to conduct large PK and dosing trials in this patient population. Capitalizing on all available data sources to characterize the PK and safety of these two drugs is therefore essential.  Data from three Pediatric Trials Network clinical trials (all registered via NCT01431326NCT01728363, and NCT01744730) were studied and submitted to the FDA using the NIH/BPCA 409I mechanism.



    Analysis ongoing identifiers:
    NCT01431326, NCT01728363, NCT01744730


    • PTN determines appropriate TMP/SMX dosing in infants and children The Pediatric Trials Network (PTN), with funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), recently completed a multicenter study of trimethoprim/sulfamethoxazole (TMP/SMX) to determine appropriate dosing for infants and children. The results of the study were published in the journal Antimicrobial Agents and Chemotherapy on Oct. 30. TMP/SMX is ...