Medical History in Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections – Clindamycin

Medical History data
Study Description
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 clindamycin therapy at the protocol-specified doses was safe for premature infants with complicated intra-abdominal infections. Only one adverse event was attributed to the study drug, and mortality within 30 days post-treatment was 7% in the cohort receiving the ampicillin, gentamycin, and clindamycin drug regimen (Group 2). None of the outcomes of special interest were attributable to clindamycin. Therapeutic success was achieved in 87% of participants. Collected PK data validated the protocol-specified dosing regimen. A total of 257 participants were enrolled and received at least 1 study dose across groups. Out of these, a total of 46 participants were enrolled and dosed in the Group 2 drug regimen (ampicillin, gentamicin and clindamycin).