Adverse Event in Ampicillin Pharmacokinetics and Safety in Infants

Adverse Event data
Study Description
Aim: NICHD-2012-AMP01 study was designed to characterize the pharmacokinetics (PK) and safety of ampicillin administered to infants per standard of care to address gap in pediatric labeling. Methods: The PK analysis include ampicillin data from NICHD-2011-POP01 study. The safety analysis includes ampicillin data from 1) NICHD-2011-POP01 study 2) Pediatric Pharmacology Research Unit (PPRU) study and 3) Pediatrix Medical Group Database. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported. From the Pediatrix database Adverse events during ampicillin exposure were uncommon. Shorter dosing intervals were associated with more frequent hematologic AEs for infants of all age groups. All infants with evaluable PK samples and receiving ampicillin while enrolled in the PPRU Antimicrobial PK in High Risk Infants study