Dataset from Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Trimethoprim-Sulfamethoxazole

Aim: Characterize the pharmacokinetics (PK) of enteral TMP and SMX administered to children per standard of care (SOC) as prescribed by their treating caregiver.\n\nMethods: The PK analyses include plasma TMP-SMX data following enteral administration from NICHD-2011-POP01, a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who received drugs per SOC, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including TMP-SMX, and is actively enrolling participants for other DOIs. \n\nResults: A one-compartment model with first-order absorption and elimination described the PK data for both TMP and SMX. No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to TMP-SMX were reported.