Data Attestation in Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections – Clindamycin

Data Attestation 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).

数据鉴证数据集
研究概况
NICHD-2013-ABS01是一项前瞻性、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，在伴复杂性腹腔感染婴儿的指定组或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（pharmacokinetics, PK）研究。研究结果显示，按方案规定剂量使用克林霉素治疗，对伴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给药方案（第2组）的队列中，治疗后30天内的死亡率为7%。无任何特定关注结局被归因于克林霉素。87%的受试者实现了治疗成功。所收集的群体药代动力学数据验证了方案规定的给药方案。各队列总计纳入257名受试者，且均接受了至少1次研究给药。其中，第2组给药方案（氨苄西林、庆大霉素与克林霉素）共纳入并给药46名受试者。