ACY01 Pharmacokinetics Dataset in An Open Label Study to Describe the Pharmacokinetics of Acyclovir in Premature Infants

Data on specimen collection and results of PK testing
Study Description
An open label study to describe the safety and pharmacokinetics of intravenous acyclovir in premature infants with suspected systemic herpes simplex virus (HSV) infection. Dosing group assignments were based on gestational age (GA) and postnatal age (PNA). Protocol version 1.0 (n=13) included four groups, with GA 23-42 weeks and PNA up to 60 days; version 2.0 (n=19) included three groups, with GA 23-34 weeks and PNA <45 days. Acyclovir was administered every 8-12 hours for up to 3 days and was well tolerated. This study was conducted by the Pediatric Trials Network under the Best Pharmaceuticals for Children Act Program. Biospecimens were collected but are not currently available. Premature infants with suspected systemic herpes simplex virus infection

标本采集与药代动力学（Pharmacokinetics, PK）检测结果数据集
研究概况
本研究为一项开放标签研究，旨在描述疑似全身性单纯疱疹病毒（Herpes Simplex Virus, HSV）感染的早产儿静脉注射阿昔洛韦的安全性与药代动力学特征。给药分组依据胎龄（Gestational Age, GA）与出生后年龄（Postnatal Age, PNA）确定。方案1.0版（n=13）共设4个组别，纳入胎龄23~42周、出生后年龄不超过60天的受试者；方案2.0版（n=19）共设3个组别，纳入胎龄23~34周、出生后年龄小于45天的受试者。阿昔洛韦每8~12小时给药一次，最长疗程为3天，受试者耐受性良好。本研究由儿科试验网络（Pediatric Trials Network）依托《儿童最佳药品法案》（Best Pharmaceuticals for Children Act）项目开展。已采集生物标本，但目前暂不可获取。研究对象：疑似全身性单纯疱疹病毒感染的早产儿