Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections - Metronidazole

NICHD-2013-ABS01 was a prospective, open-label, partially randomized, multicenter trial. The primary objective of this study was to evaluate the safety of drug regimens consisting of ampicillin, metronidazole, clindamycin, piperacillin-tazobactam, and gentamycin in assigned or standard of care groups of infants with complicated intra-abdominal infections. Secondary objectives included evaluations of efficacy and population pharmacokinetics (PK). Results demonstrate that metronidazole therapy at the protocol-specified doses was safe for premature infants with complicated intra-abdominal infections (Group 1) and late preterm/term infants (Group 4). Therapeutic success was achieved in 81% and 96% of participants in Groups 1 and 4, respectively. Only one AE in each group was attributable to study drug. None of the outcomes of special interest were attributable to metronidazole. Collected PK data validated the protocol-specified dosing regimen.