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

Basic study visit and study drug administration data
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

基础研究访视与研究药物给药数据集
研究概况
本研究为一项开放标签研究，旨在明确疑似全身性单纯疱疹病毒 (herpes simplex virus, HSV) 感染早产儿静脉注射阿昔洛韦的安全性与药代动力学特征。给药分组方案基于胎龄（gestational age, GA）与出生后年龄（postnatal age, PNA）制定。1.0版方案（样本量n=13）共设4个分组，纳入胎龄23~42周、出生后年龄不超过60天的受试者；2.0版方案（样本量n=19）共设3个分组，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，最长给药时长为3天，受试者整体耐受性良好。本研究由儿科试验网络（Pediatric Trials Network）依托《儿童最佳药品法案》项目开展。研究过程中收集了生物样本，但目前暂不可获取。本研究的受试对象为疑似全身性单纯疱疹病毒感染的早产儿。