Z01: Study Drug Manufacturers and Lot Numbers in Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections – Clindamycin

Z01: Study Drug Manufacturers and Lot Numbers 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).

Z01：研究药物生产商及批号数据集
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。本研究的主要目的为评估由氨苄西林、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，针对合并复杂性腹腔感染的婴儿在指定给药组或标准护理组中的安全性。次要研究目的包括疗效评估与群体药代动力学（population pharmacokinetics，PK）研究。
研究结果显示，按方案规定剂量使用的克林霉素治疗，对于合并复杂性腹腔感染的早产儿安全性良好。仅1例不良事件被归因于研究药物；接受氨苄西林、庆大霉素与克林霉素联合给药方案（第2组）的队列中，治疗后30天内死亡率为7%。无任何特殊关注的结局指标与克林霉素相关。87%的受试者实现了治疗成功。所收集的药代动力学数据验证了方案规定的给药方案。所有组别中共纳入257名受试者，且均接受了至少1次研究给药。其中，接受第2组给药方案（氨苄西林、庆大霉素与克林霉素）的受试者共计46名。