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.

Summary

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) will be studied and submitted to the FDA using the NIH/BPCA 409I mechanism.

OVERVIEW

Status:
Analysis ongoing

ClinicalTrials.gov identifiers:
NCT01431326, NCT01728363, NCT01744730

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