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

Medical Review 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 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. A total of 257 participants were enrolled and received at least 1 study dose across groups. Out of these, a total of 62 participants were enrolled and dosed in the Group 1 drug regimen, and 55 in Group 4.

医学审查数据集
研究概况
NICHD-2013-ABS01为一项前瞻性、开放标签、部分随机化多中心临床试验。本研究的主要目标为评估由氨苄西林、甲硝唑、克林霉素、哌拉西林-他唑巴坦及庆大霉素组成的给药方案，在合并复杂性腹腔感染的婴儿指定治疗组与标准治疗组中的安全性。次要研究目标包括疗效评估与群体药代动力学（population pharmacokinetics, PK）。
研究结果显示，按照试验方案指定剂量给药的甲硝唑治疗，对于合并复杂性腹腔感染的早产儿（第1组）与晚期早产/足月儿（第4组）均具有安全性。第1组与第4组受试者的治疗成功率分别为81%与96%。两组各仅发生1例与研究药物相关的不良事件（Adverse Event, AE）。无任何特殊关注的结局事件与甲硝唑相关。所收集的药代动力学数据验证了试验方案指定的给药方案。本次研究共纳入257名受试者，所有受试者均接受了至少1次研究给药。其中，第1组给药方案共纳入62名受试者并完成给药，第4组则为55名。