Assessing the safety and pharmacokinetics of trimethoprim-sulfamethoxazole (TMP-SMX) 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) were studied and submitted to the FDA using the NIH/BPCA 409I mechanism.
Publications
OVERVIEW
Status:
Analysis ongoing
ClinicalTrials.gov identifiers:
NCT01431326, NCT01728363, NCT01744730
Label Change
Trimethoprim-Sulfamethoxazole (TMP-SMX) is approved for the treatment of urinary tract infections, shigellosis, acute middle ear infections, and Pneumocystis jiroveci infections in children 2 months of age and older, and as preventative care against susceptible bacteria. TMP-SMX is commonly prescribed off-label to treat community-acquired methicillin-resistant Staphylococcus areus infections. Updates to the label include addition of pharmacokinetics information for pediatric patients.