Ampicillin PK Analysis in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Ampicillin

Ampicillin PK Analysis Data
Study Description
Aim: Characterize the pharmacokinetics (PK) of ampicillin administered to children per standard of care to address gap in pediatric labeling. Methods: The PK and safety analyses include ampicillin data from NICHD-2011-POP01 (“Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care”), a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including ampicillin, and continues to enroll participants under other DOIs. Data from NICHD-2011-POP01 (Ampicillin) was analyzed as part of NICHD-2012-AMP01 study. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported. A total of 75 participants were consented for the study and had available PK samples. Participants were enrolled based on PNA and GA. One participant with a PNA of 30 days was enrolled into the study and is included in the 8-28 day group