Hematology Laboratory Tests in Antibiotic Safety in Infants with Complicated Intra-Abdominal Infections – Clindamycin

Hematology Laboratory Tests 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).

血液学实验室检测数据集
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药物方案，在合并复杂性腹腔感染的婴儿患者的指定治疗组与标准治疗组内的安全性。次要研究目的包括评估疗效与群体药代动力学（population pharmacokinetics，PK）。
研究结果显示，方案规定剂量的克林霉素治疗对于合并复杂性腹腔感染的早产儿具有安全性。仅1例不良事件被归因于研究药物；接受氨苄西林、庆大霉素及克林霉素药物方案（第2组）的队列中，治疗后30天内的死亡率为7%。无任何特殊关注的结局事件可归因于克林霉素。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。本研究共纳入257名受试者，各组受试者均至少接受了1次研究给药。其中，第2组药物方案（氨苄西林、庆大霉素及克林霉素）共入组并给药46名受试者。