Pharmacokinetics Dataset in Multiple Dose Pharmacokinetic Study of Meropenem in Young Infants (<91 days) with Suspected or Complicated Intra-abdominal Infections
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https://dash.nichd.nih.gov/dataset/2136
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资源简介:
Timing, collection site, and results of pharmacokinetic (PK) testing, whether scavenge samples were used, records excluded from analysis, details of study drug administration, and demographics and pertinent clinical data of participants who had PK testing
Study Description
An open-label, multiple-dose study to determine the safety, tolerability, and pharmacokinetics of meropenem in preterm and term infants less than 91 days of age with suspected or confirmed intra-abdominal infections. Biospecimens are available.
Infants less than 91 days of age with suspected or confirmed intra-abdominal infection
本数据集涵盖药代动力学(pharmacokinetic, PK)检测的时间安排、样本采集地点与检测结果,是否使用了临床残留样本(scavenge samples),分析过程中排除的记录详情,研究药物的给药细节,以及接受PK检测的受试者的人口统计学特征与相关临床数据。
研究概况
本研究为开放标签、多剂量给药研究,旨在评估年龄小于91日龄的早产及足月腹腔内感染疑似或确诊婴儿使用美罗培南的安全性、耐受性及药代动力学特征。本研究可提供生物标本(biospecimens)。
受试对象:年龄小于91日龄、疑似或确诊腹腔内感染的婴儿。
创建时间:
2022-06-03



