中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2400081254
最近更新日期： Date of Last Refreshed on：	2024-02-27 14:59:14
注册时间： Date of Registration：	2024-02-27 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	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
Public title：	Pharmacokinetic study of vancomycin and meropenem and a pilot paediatric antibiotic stewardship program
注册题目简写：
English Acronym：
研究课题的正式科学名称：	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
Scientific title：	Pharmacokinetic study of vancomycin and meropenem and a pilot paediatric antibiotic stewardship program
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	Ng Wai Yin	研究负责人：	Ng Wai Yin
Applicant：	Ng Wai Yin	Study leader：	Ng Wai Yin
申请注册联系人电话： Applicant telephone：	+852 3505 6959	研究负责人电话： Study leader's telephone：	+852 3505 6959
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	ritang@cuhk.edu.hk	研究负责人电子邮件： Study leader's E-mail：	ritang@cuhk.edu.hk
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China	研究负责人通讯地址：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China
Applicant address：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China	Study leader's address：	Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	香港中文大學
Applicant's institution：	Chinese University of Hong Kong
研究负责人所在单位：	香港中文大學
Affiliation of the Leader：	Chinese University of Hong Kong

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	2023.034	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會
Name of the ethic committee：	Joint CUHK-NTEC Clinical Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2023-02-13 00:00:00
伦理委员会联系人：	Envy Lee
Contact Name of the ethic committee：	Envy Lee
伦理委员会联系地址：	中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓
Contact Address of the ethic committee：	8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+852 3505 3935	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

Department of Microbiology/CUHK

Primary sponsor：

Department of Microbiology/CUHK

研究实施负责（组长）单位地址：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

Primary sponsor's address：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中國	省(直辖市)：	香港特別行政區	市(区县)：
Country：	China	Province：	Hong Kong Special Administrative Region	City：
单位(医院)：	Department of Microbiology/CUHK	具体地址：	Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories
Institution hospital：	Department of Microbiology/CUHK	Address：	Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories

经费或物资来源：

Department of Microbiology/CUHK

Source(s) of funding：

Department of Microbiology/CUHK

研究疾病：

Sepsis

Target disease：

Sepsis

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

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

Objectives of Study：

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

药物成份或治疗方案详述：

Part 1. A total of 50 patients prescribed with vancomycin in NICU and PICU and other paediatric units will be recruited in the first 24-month period. Part 2. A total of 100 patients prescribed with meropenem in NICU and PICU and other paediatric units will be recruited in the first 24-month period. Part 3. A total of 50 patients prescribed with at least one of the selected antibiotics (vancomycin or meropenem) for at least 48 hours will be recruited from Department of Paediatrics in Prince of Wales Hospital in the 25th-36th month period in the ASP program. The vancomycin dose optimization calculator guided by Bayesian estimated PK/PD target will be validated in clinical setting in the 25th-36th month period as part of the ASP program

Description for medicine or protocol of treatment in detail：

Part 1. A total of 50 patients prescribed with vancomycin in NICU and PICU and other paediatric units will be recruited in the first 24-month period. Part 2. A total of 100 patients prescribed with meropenem in NICU and PICU and other paediatric units will be recruited in the first 24-month period. Part 3. A total of 50 patients prescribed with at least one of the selected antibiotics (vancomycin or meropenem) for at least 48 hours will be recruited from Department of Paediatrics in Prince of Wales Hospital in the 25th-36th month period in the ASP program. The vancomycin dose optimization calculator guided by Bayesian estimated PK/PD target will be validated in clinical setting in the 25th-36th month period as part of the ASP program

纳入标准：

Inclusion criteria

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

Exclusion criteria：

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

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2027-02-28 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-03-01 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：	Part 1	样本量：	50
Group：	Part 1	Sample size：	50
干预措施：	Nil	干预措施代码：
Intervention：	Nil	Intervention code：

组别：	Part 2	样本量：	100
Group：	Part 2	Sample size：	100
干预措施：	Nil	干预措施代码：
Intervention：	Nil	Intervention code：

组别：	Part 3	样本量：	50
Group：	Part 3	Sample size：	50
干预措施：	Nil	干预措施代码：
Intervention：	Nil	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中國	省(直辖市)：	香港特別行政區	市(区县)：
Country：	China	Province：	Hong Kong SAR	City：
单位(医院)：	威爾士親王醫院	单位级别：	三甲醫院
Institution hospital：	Prince of Wales Hospital	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	The PK/PD target of vancomycin (AUC/MIC)	指标类型：	主要指标
Outcome：	The PK/PD target of vancomycin (AUC/MIC)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	A pilot paediatric ASP program	指标类型：	主要指标
Outcome：	A pilot paediatric ASP program	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	The PK/PD target of meropenem (T>MIC)	指标类型：	主要指标
Outcome：	The PK/PD target of meropenem (T>MIC)	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	skin prick samples	组织：
Sample Name：	skin prick samples	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

标本中文名：	venous blood samples	组织：
Sample Name：	venous blood samples	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age		岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

Randomization Procedure (please state who generates the random number sequence and by what method)：

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	否No
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	will be through publications and presentations at conferences relevant to the speciality. We aim to publish the findings in peer reviewed journals
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	will be through publications and presentations at conferences relevant to the speciality. We aim to publish the findings in peer reviewed journals
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	All data management will be undertaken by the Prince of Wales Hospital. Standard operating procedures will be in place for the collection and handling of data received at the Unit. All study data will be entered into a secure electronic trial database with restricted access. Data collected on the data collection forms and entered into the electronic database will only identify the participants by a unique trial number
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	All data management will be undertaken by the Prince of Wales Hospital. Standard operating procedures will be in place for the collection and handling of data received at the Unit. All study data will be entered into a secure electronic trial database with restricted access. Data collected on the data collection forms and entered into the electronic database will only identify the participants by a unique trial number
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2024-02-27 14:58:50