今天是:2019-07-21 星期日

沈阳地区多家重症监护病房 CRE 主动筛查的研究
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注册号:

Registration number:

ChiCTR1900021019 

最近更新日期:

Date of Last Refreshed on:

2019-01-25 

注册时间:

Date of Registration:

2019-01-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

沈阳地区多家重症监护病房 CRE 主动筛查的研究 

Public title:

A study for screening in multiple intensive care units in Shenyang 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

沈阳地区多家重症监护病房 CRE 主动筛查的研究 

Scientific title:

A study for CRE screening in multiple intensive care units in Shenyang 

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:

李国福 

研究负责人:

李国福 

Applicant:

Li Guofu 

Study leader:

Li Guofu 

申请注册联系人电话:

Applicant telephone:

+86 18940251808 

研究负责人电话:

Study leader's telephone:

+86 18940251808 

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:

ligf2018@126.com 

研究负责人电子邮件:

Study leader's E-mail:

ligf2018@126.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:

辽宁省沈阳市铁西区滑翔路39号二号楼九楼ICU 

研究负责人通讯地址:

辽宁省沈阳市铁西区39号二号楼九楼ICU 

Applicant address:

ICU, the Ninth Floor, Building 2, 39 Huaxiang Road, Tiexi District, Shenyang, Liaoning, China 

Study leader's address:

ICU, the Ninth Floor, Building 2, 39 Huaxiang Road, Tiexi District, Shenyang, Liaoning, 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:

中国医科大学附属盛京医院ICU 

Applicant's institution:

Shengjing Hospital of China Medical 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:

2018PS446K 

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:

中国医科大学附属盛京医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Shengjing Hospital of China Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-08-10 

伦理委员会联系人:

赵玉虹 

Contact Name of the ethic committee:

Zhao Yuhong 

伦理委员会联系地址:

辽宁省沈阳市和平区三好街36号 

Contact Address of the ethic committee:

ICU, the Ninth Floor, Building 2, 39 Huaxiang Road, Tiexi District, Shenyang, Liaoning, 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:

中国医科大学附属盛京医院 

Primary sponsor:

Shengjing Hospital of China Medical University 

研究实施负责(组长)单位地址:

中国医科大学附属盛京医院 

Primary sponsor's address:

ICU, the Ninth Floor, Building 2, 39 Huaxiang Road, Tiexi District, Shenyang, Liaoning, 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):

辽宁省

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shengyang

单位(医院):

中国医科大学附属盛京医院

具体地址:

铁西区滑翔路39号二号楼九楼ICU

Institution
hospital:

Shengjing Hospital of China Medical University

Address:

ICU, the Ninth Floor, Building 2, 39 Huaxiang Road, Tiexi District

经费或物资来源:

无 

Source(s) of funding:

N/A 

研究疾病:

碳青霉烯类耐药肠杆菌科细菌感染 

Target disease:

Carbapenem-resistant Enterobacteriaceae bacterial infection 

研究疾病代码:

 

Target disease code:

 

研究类型:

筛查 

Study type:

Screening 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

对沈阳地区的碳青霉烯类耐药肠杆菌科细菌感染情况筛查,为进一步的诊断及治疗奠定流行病学基础。 

Objectives of Study:

Screening for carbapenem-resistant Enterobacteriaceae bacterial infections in Shenyang which can provides an epidemiological basis for further diagnosis and treatment. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. 年龄大于 18 周岁; 2. 参研单位所有收治的患者,患者可来自急诊科,或者由本院其他病房转入, 或者其他医院或者其他任何地方转入。 

Inclusion criteria

1. Aged over 18 years; 2. All patients admitted to the research unit from the emergency department, or transferred from other wards of the hospital, or transferred to other hospitals or anywhere else. 

排除标准:

1. 转入时已确定存在 CRE 感染; 2. 肛门手术患者; 3. 其它原因导致无法进行肛试子检查. 

Exclusion criteria:

1. CRE infection is confirmed at the time of transfer; 2. Anal surgery patients; 3. Other reasons lead to failure to perform anal test. 

研究实施时间:

Study execute time:

From2019-02-01To 2020-02-01 

干预措施:

Interventions:

组别:

连续病例

样本量:

1000

Group:

Case Series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

N/A

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liao ning 

City:

Shen yang 

单位(医院):

中国医科大学附属盛京医院 

单位级别:

三级甲等 

Institution
hospital:

Shengjing Hospital of China Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

CRE 检出率

指标类型:

主要指标 

Outcome:

The rate of CRE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

28天死亡率

指标类型:

次要指标 

Outcome:

28-day mortality rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU住院死亡率

指标类型:

次要指标 

Outcome:

ICU hospital mortality rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ICU 住院时间

指标类型:

次要指标 

Outcome:

ICU hospital stay

Type:

Secondary 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:

粪便

组织:

Sample Name:

stool

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:

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):

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

N/A

盲法:

N/A

Blinding:

N/A

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-25
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