今天是:2019-06-17 星期一

美罗培南在重症肺部感染患者中的群体药动学/药效学研究
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注册号:

Registration number:

ChiCTR1900020672 

最近更新日期:

Date of Last Refreshed on:

2019-01-12 

注册时间:

Date of Registration:

2019-01-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

美罗培南在重症肺部感染患者中的群体药动学/药效学研究 

Public title:

Population pharmacokinetics and pharmacodynamics of meropenem in patients with severe pulmonary infection 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

美罗培南在重症肺部感染患者中的群体药动学/药效学研究 

Scientific title:

Population pharmacokinetics and pharmacodynamics of meropenem in patients with severe pulmonary infection 

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:

邹杨 

研究负责人:

罗红 

Applicant:

Zou Yang 

Study leader:

Luo Hong 

申请注册联系人电话:

Applicant telephone:

+86 15298363690 

研究负责人电话:

Study leader's telephone:

+86 13607435199 

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:

zyang798141474@126.com 

研究负责人电子邮件:

Study leader's E-mail:

luohong1003@163.com 

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:

湖南省长沙市人民中路139号 

研究负责人通讯地址:

湖南省长沙市人民中路139号 

Applicant address:

139 Middle Renmin Road, Changsha, Hu'nan, China 

Study leader's address:

139 Middle Renmin Road, Changsha, Hu'nan, 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:

中南大学湘雅二医院 

Applicant's institution:

The Second Xiangya Hospital of Central South University 

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:

2019-005 

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:

中南大学湘雅二医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Second Xiangya Hospital, Central South University  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-02 

伦理委员会联系人:

段艳 

Contact Name of the ethic committee:

Duan Yan 

伦理委员会联系地址:

湖南省长沙市人民中路139号 

Contact Address of the ethic committee:

139 Middle Renmin Road, Changsha, Hu'nan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

中南大学湘雅二医院 

Primary sponsor:

The Second Xiangya Hospital of Central South University 

研究实施负责(组长)单位地址:

湖南省长沙市人民中路139号 

Primary sponsor's address:

139 Middle Renmin Road, Changsha, Hu'nan, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖南省

市(区县):

长沙市

Country:

China

Province:

Hunan

City:

Changsha

单位(医院):

中南大学湘雅二医院

具体地址:

湖南省长沙市人民中路139号

Institution
hospital:

The Second Xiangya Hospital of Central South University

Address:

139 Middle Renmin Road, Changsha, Hu'nan, China

经费或物资来源:

个人科研经费 

Source(s) of funding:

Personal research funds 

研究疾病:

肺部感染 

Target disease:

pulmonary infection 

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:

上市后药物 

Study phase:

研究目的:

⑴建立美罗培南血药浓度测定的全自动二维液相分析技术,实时监测重症感染患者美罗培南血药浓度; ⑵对美罗培南群体药动学模型进行外部验证,选择最适模型进行群体药动学/药效学研究; ⑶探讨美罗培南药效学指标与由多种革兰阴性杆菌所致肺部感染的临床疗效、生存率、住院复发率、耐药率之间的相关性,并确定药效学指标阈值; ⑷结合最适PPK 模型与 Bayes 反馈法,预测美罗培南血药浓度,用以指导美罗培南个体化给药,并结合实际血药浓度监测结果和临床疗效进一步优化给药方案。 

Objectives of Study:

(1) Establish automatic two-dimensional liquid phase analysis technology for meropenem serum concentration and monitor meropenem serum concentration of patients with severe infection in real time; (2) For the external validation of meropenem population pharmacokinetics model, select the optimal model for the population pharmacokinetics and pharmacodynamics research; (3) Explore the correlation between the pharmacodynamic indexes of meropenem and the clinical efficacy, survival rate, hospitalization recurrence rate and drug resistance rate of pulmonary infection caused by various gram-negative bacilli, and determine the threshold of pharmacodynamic indexes; (4) The optimal PPK model was combinated with Bayes feedback method to predict the meropenem serum concentration, in order to guide meropenem personalized drug delivery and further optimize the drug delivery program, incorporating the actual blood concentration and clinical efficacy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

⑴重症肺部感染患者; ⑵有明确使用美罗培南的用药指征; ⑶标本培养分离出革兰阴性杆菌; ⑷美罗培南连续用药时间超过2天; ⑸至少能得到一个稳态血药浓度; ⑹年龄>18岁。 

Inclusion criteria

(1) Patients with severe pulmonary infection; (2) Indications for meropenem clearly; (3) Isolated Gram negative bacillus by specimen culture. (4) Meropenem continuous duration more than 2 days; (5) At least one steady-state meropenem serum concentration ; (6) Aged at least 18 years. 

排除标准:

⑴孕妇、哺乳期妇女; ⑵对碳青霉烯类药物过敏; ⑶同时使用丙戊酸钠; ⑷入组前已有革兰阳性球菌,病毒,真菌感染。 

Exclusion criteria:

(1) pregnant or lactating women; (2) Allergy to carbapenems; (3) Simultaneous use of sodium valproate; (4) Infected by gram positive cocci, virus, fungal before joining the group. 

研究实施时间:

Study execute time:

From2019-01-21To 2020-03-01 

干预措施:

Interventions:

组别:

Case series

样本量:

60

Group:

Case series

Sample size:

干预措施:

美罗培南

干预措施代码:

Intervention:

meropenem

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南省 

市(区县):

长沙市 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

中南大学湘雅二医院 

单位级别:

三级甲等医院 

Institution
hospital:

The Second Xiangya Hospital of Central South University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血药浓度

指标类型:

主要指标 

Outcome:

Blood concentration

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:

血液

组织:

Sample Name:

blood

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 18 years
最大 Max age 90 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

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

试验记录将于2021年12月在 ResMan上管理。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Test record in December 2021 on ResMan management.

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:

ResMan原始数据库

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

ResMan original database

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-12
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