Physical Examination in Ampicillin Pharmacokinetics and Safety in Infants

Physical Examination data
Study Description
Aim: NICHD-2012-AMP01 study was designed to characterize the pharmacokinetics (PK) and safety of ampicillin administered to infants per standard of care to address gap in pediatric labeling. Methods: The PK analysis include ampicillin data from NICHD-2011-POP01 study. The safety analysis includes ampicillin data from 1) NICHD-2011-POP01 study 2) Pediatric Pharmacology Research Unit (PPRU) study and 3) Pediatrix Medical Group Database. Results: No AEs or SAEs related to study procedures were reported. No serious, unexpected, suspected, adverse reactions to Ampicillin were reported. From the Pediatrix database Adverse events during ampicillin exposure were uncommon. Shorter dosing intervals were associated with more frequent hematologic AEs for infants of all age groups. All infants with evaluable PK samples and receiving ampicillin while enrolled in the PPRU Antimicrobial PK in High Risk Infants study

体格检查数据集
研究描述
研究目的：NICHD-2012-AMP01研究旨在表征按照标准治疗方案给予婴儿氨苄西林的药代动力学（pharmacokinetics, PK）与安全性，以填补儿科用药标签的空白。
研究方法：本研究的药代动力学分析纳入了来自NICHD-2011-POP01研究的氨苄西林相关数据；安全性分析涵盖三部分数据来源：1) NICHD-2011-POP01研究数据；2) 儿科药理学研究单元（Pediatric Pharmacology Research Unit, PPRU）研究数据；3) Pediatrix医疗集团数据库数据。
研究结果：未报告与研究流程相关的不良事件（adverse events, AE）或严重不良事件（serious adverse events, SAE）；未观察到与氨苄西林相关的严重、非预期、疑似不良反应。来自Pediatrix数据库的数据显示，氨苄西林暴露期间的不良事件较为少见。对于所有年龄组的婴儿，更短的给药间隔与更频繁发生的血液学不良事件相关。所有可获取可评估药代动力学样本且在参与PPRU《高危婴儿抗菌药物药代动力学研究》期间接受氨苄西林治疗的婴儿。