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【ChiCTR2100048714】Multi-center population pharmacokinetic study of intravenous vancomycin in adults in Hong Kong and development of web-based individual dose optimization interface

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基本信息

登记号

ChiCTR2100048714

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2021-07-13

临床申请受理号

靶点

适应症

Suspected or confirmed infection by methicillin-resistant staphylococcus aureus

试验通俗题目

Multi-center population pharmacokinetic study of intravenous vancomycin in adults in Hong Kong and development of web-based individual dose optimization interface

试验专业题目

Multi-center population pharmacokinetic study of intravenous vancomycin in adults in Hong Kong and development of web-based individual dose optimization interface

申办单位信息

申请人联系人

申请人名称

联系人邮箱

联系人邮编

联系人通讯地址

临床试验信息

试验目的

1. To develop and validate a model characterizing the population pharmacokinetics of intravenous vancomycin in Hong Kong adults using prospectively collected rich therapeutic drug monitoring data from multiple hospitals under Hospital Authority 2. To develop a web-based interface to enable Bayesian estimates of individual vancomycin exposure and evidence-based optimization of individual empirical and TDM-based dosing regimen 3. To evaluate the clinical utility of the developed interface

试验分类

试验类型

历史对照研究

试验分期

其它

随机化

N/A

盲法

Not stated

试验项目经费来源

N/A

试验范围

目标入组人数

350

实际入组人数

第一例入组时间

2021-07-01

试验终止时间

2022-08-31

是否属于一致性

入选标准

(1) At least 18 years old; (2) Admitted to one of the following hospitals under Hospital Authority: Pamela Youde Nethersole Eastern Hospital, Ruttonjee and Tang Shiu Kin Hospitals, Queen Mary Hospital, Queen Elizabeth Hospital, Kwong Wah Hospital, United Christian Hospital, Prince of Wales Hospital, Princess Margaret Hospital, or Tuen Mun Hospital; and (3) prescribed intermittent intravenous vancomycin.；

排除标准

(1) Documented trypanophobia or hemophobia; (2) Subjects prescribed any form of renal replacement therapy to be started before or during IV vancomycin treatment.；

研究者信息

研究负责人姓名

试验机构

N/A

研究负责人电话

研究负责人邮箱

研究负责人邮编

联系人通讯地址

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