Enroll in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Trimethoprim-Sulfamethoxazole

Enrollment Form
Study Description
Aim: Characterize the pharmacokinetics (PK) of enteral TMP and SMX administered to children per standard of care (SOC) as prescribed by their treating caregiver.

Methods: 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.

Results: 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. Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver; who provided consent/assent and were not pregnant were enrolled. 188 enrolled, and 153 were in the PK population.