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【ChiCTR2400081254】萬古黴素和美羅培南的藥代動力學研究和兒科先導抗生素導向計劃

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基本信息

登记号

ChiCTR2400081254

试验状态

正在进行

药物名称

万古霉素+美罗培南

药物类型

规范名称

万古霉素+美罗培南

首次公示信息日的期

2024-02-27

临床申请受理号

靶点

适应症

Sepsis

试验通俗题目

萬古黴素和美羅培南的藥代動力學研究和兒科先導抗生素導向計劃

试验专业题目

萬古黴素和美羅培南的藥代動力學研究和兒科先導抗生素導向計劃

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

1. To provide evidence-based recommendation for vancomycin in paediatric patients by development of a local population pharmacokinetic model using vancomycin therapeutic drug monitoring 2. To provide evidence-based recommendation for continuous-infusion meropenem in paediatric patients by development of a local population pharmacokinetic model using meropenem therapeutic drug monitoring with the aim to predict T>MIC (percentage of time that drug concentration exceeds the MIC) 3. To evaluate the implementation of paediatric antibiotic stewardship program (ASP) in paediatric patients and the impact on microbiology and clinical outcomes , including the study of vancomycin dose optimization calculator guided by Bayesian estimated PK/PD target to estimate the 24-hour AUC/MIC (24 hour area under the concentration-time curve to MIC ratio) and evaluation of its impact on microbiology and clinical outcomes, including PK/PD attainment

试验分类

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试验类型

横断面

试验分期

其它

随机化

N/A

盲法

N/A

试验项目经费来源

Department of Microbiology/CUHK

试验范围

目标入组人数

100;50

实际入组人数

第一例入组时间

2024-03-01

试验终止时间

2027-02-28

是否属于一致性

入选标准

Inclusion criteria (Part 1): Patients in NICU and PICU and other paediatric units prescribed with intravenous vancomycin Inclusion criteria (Part 2): Patients in NICU and PICU and other paediatric units prescribed with intravenous meropenem Inclusion criteria (Part 3): Receipt of at least one of the selected antibiotics (intravenous vancomycin or intravenous meropenem) for at least 48 hours；

排除标准

Exclusion criteria (Part 1): Age more than 18 years Patients with extreme prematurity (born before 28 weeks of pregnancy) Subject’s parent or guardian who is not willing to sign informed consent Exclusion criteria (Part 2): Age more than 18 years Patients with extreme prematurity (born before 28 weeks of pregnancy) Subject’s parent or guardian who is not willing to sign informed consent Exclusion criteria (Part 3) Age more than 18 years；

研究者信息

研究负责人姓名

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试验机构

Department of Microbiology/CUHK

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研究负责人邮编

联系人通讯地址

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