今天是:2019-09-17 星期二

碳青霉烯类耐药的肠杆菌科细菌和铜绿假单胞菌引起的血流感染的成本效益和结局分析
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注册号:

Registration number:

ChiCTR1900025064 

最近更新日期:

Date of Last Refreshed on:

2019-08-09 

注册时间:

Date of Registration:

2019-08-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

碳青霉烯类耐药的肠杆菌科细菌和铜绿假单胞菌引起的血流感染的成本效益和结局分析 

Public title:

A study for Cost-Effectiveness and Consequence in Carbapenem-resistant Enterobacteriaceae and Pseudomonas aeruginosa bloodstream infections  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

耐碳青霉烯类肠杆菌科细菌和铜绿假单胞菌血流感染患者的成本效益和预后研究 

Scientific title:

A study for Cost-Effectiveness and Consequence in Carbapenem-resistant Enterobacteriaceae and Pseudomonas aeruginosa bloodstream infections  

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:

肖婷婷 

研究负责人:

肖永红 

Applicant:

Tingting Xiao 

Study leader:

Yonghong Xiao 

申请注册联系人电话:

Applicant telephone:

+86 13588831901 

研究负责人电话:

Study leader's telephone:

+86 15168338848 

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:

xiaotingting@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

xiaoyonghong@zju.edu.cn 

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:

浙江省杭州市上城区庆春路79号 

研究负责人通讯地址:

浙江省杭州市上城区庆春路79号 

Applicant address:

79 Qingchun Road, Hangzhou, Zhejiang, China 

Study leader's address:

79 Qingchun Road, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Applicant's institution:

the First Affiliated Hospital, College of Medicine, Zhejiang 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:

2019-693 

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:

浙江大学医学院附属第一医院科研伦理委员会 

Name of the ethic committee:

Research Ethics Committee of the First Affiliated Hospital, College of Medicine, Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-05-17 

伦理委员会联系人:

郑敏 

Contact Name of the ethic committee:

Min Zheng 

伦理委员会联系地址:

浙江大学医学院附属第一医院 

Contact Address of the ethic committee:

the First Affiliated Hospital, Zhejiang University, 79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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:

浙江大学医学院附属第一医院 

Primary sponsor:

the First Affiliated Hospital, College of Medicine, Zhejiang University 

研究实施负责(组长)单位地址:

浙江省杭州市上城区庆春路79号 

Primary sponsor's address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, 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):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属第一医院

具体地址:

浙江省杭州市上城区庆春路79号

Institution
hospital:

the First Affiliated Hospital, College of Medicine, Zhejiang University, Zhejiang, China

Address:

79 Qingchun Road, Shangcheng District, Hangzhou, Zhejiang, China

经费或物资来源:

本研究由浙一医院传染病国家重点实验室及MSD资助 

Source(s) of funding:

The study is sponsored by State Key Laboratory for Diagnosis & Treatment of Infectious Diseases and MSD (China)  

研究疾病:

血流感染 

Target disease:

bloodstream infections 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1)估计耐碳青霉烯类肠杆菌和铜绿假单胞菌血流感染患者的成本效益和后果; 2)其次,为政策制定者提供依据以加强耐药菌(AMR)遏制。 

Objectives of Study:

Firstly, to estimate the cost-effectiveness and consequence in Carbapenem-resistant Enterobacteriaceae and Pseudomonas aeruginosa bloodstream infectious patients. Secondly, providing evidence to policy-maker to enhance the AMR containment.  

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:

(a)肠杆菌科细菌和铜绿假单胞菌血培养阳性; (b)符合血流感染感染的临床表现; (c)住院治疗,并且有完整的临床信息。 

Inclusion criteria

1. Blood culture positive for Enterobacteriaceae and Pseudomonas aeruginosa; 2. Clinical manifestations of infection; 3. Hospitalization and complete clinical data.  

排除标准:

(a)年龄<16岁; (b)医疗记录不完整; (c)血流感染后的治疗时间<48小时。 

Exclusion criteria:

1. Aged <16 years old; 2. KP isolated but with incomplete medical records; 3. treatment time after bloodstream infection <48 hours.  

研究实施时间:

Study execute time:

From2019-05-01To 2020-11-30 

干预措施:

Interventions:

组别:

Case series

样本量:

1000

Group:

Case series

Sample size:

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:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

the First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

结局

指标类型:

次要指标 

Outcome:

outcome

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

主要指标 

Outcome:

Cost-Effectiveness

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:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

不适用

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:

试验完成后6个月内公开/Within six months after the trial complete

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):

2020-12-01 文章

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

2020-12-01 paper

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:

根据医院电子采集和管理系统进行数据分析

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

an electronic data capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-08-09
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