General Medical History in Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants

General Medical History data
Study Description
The primary objective of this prospective, open-label, multi-center, pharmacokinetic (PK) study was to evaluate the PK and safety of IV metronidazole in premature infants <32 weeks gestational age with suspected serious infection. There were 24 participants enrolled in two age groups based on postnatal age. Each participant received metronidazole and was included in the PK population. Plasma PK was evaluated using a limited sampling scheme. A new dosing strategy based on PMA was developed to account for developmental changes in metronidazole disposition as well as for simplicity in clinical application. The dosing of 7.5 mg/kg Q12 hours in infants PMA <34 weeks and 7.5 mg/kg Q8 hours in infants with a PMA 34-40 weeks, with a loading dose of 15 mg/kg for both age cohorts would achieve therapeutic metronidazole concentrations in the majority (>75%) of infants <90 days of age. In addition, metronidazole was well tolerated in this open-label study. None of the AEs and SAEs reported was related to study drug. Premature infants <32 weeks gestation with suspected serious infection

通用医学病史数据集

研究概况
本项前瞻性、开放标签、多中心药代动力学（pharmacokinetic, PK）研究的主要目的，为评估静脉输注甲硝唑（IV metronidazole）对疑似重症感染、胎龄<32周早产儿的药代动力学特征与安全性。
本研究共纳入24名受试者，按出生后年龄划分为两个年龄组。所有受试者均接受甲硝唑治疗，且均被纳入药代动力学分析人群。
研究采用有限采样方案评估血浆药代动力学特征。
研究基于校正胎龄（postmenstrual age, PMA）制定了全新的给药方案，该方案既可适配甲硝唑体内处置过程的发育变化，又能简化临床应用流程。校正胎龄<34周的早产儿给药方案为7.5mg/kg，每12小时1次；校正胎龄34~40周的早产儿则为7.5mg/kg，每8小时1次；两个年龄组均给予15mg/kg的负荷剂量。该方案可使90日龄以下的绝大多数（>75%）早产儿体内达到治疗性甲硝唑血药浓度。
此外，本项开放标签研究中，受试者对甲硝唑耐受性良好。所有报告的不良事件（adverse event, AE）与严重不良事件（serious adverse event, SAE）均与研究药物无关。
疑似重症感染、胎龄<32周的早产儿