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 ClinicalTrials.gov: NCT01431326, NCT01728363, and NCT01744730) were studied and submitted to the FDA using the NIH/BPCA 409I mechanism.
Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children. Autmizguine J, Melloni C, Hornik C, Dallefeld S, Harper B, Yogev R, Sullivan J, Atz A, Al-Uzri A, Mendley S, Poindexter B, Mitchell J, Lewandowski A, Delmore P, Cohen-Wolkowiez M, Gonzalez D, on behalf of the Pediatric Trials Network Steering Committee.
Antimicrobial Agents and Chemotherapy • October 2017 [Free online access]
- PTN determines appropriate TMP/SMX dosing in infants and children November 13, 2017 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 ...