Today is 2019-12-10

Antimicrobial susceptibility of community-acquired respiratory tract pathogens isolated from adults in China
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注册号:

Registration number:

ChiCTR1900025062 

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:

中国成人社区下呼吸道感染中肺炎链球菌、流感嗜血杆菌和卡他莫拉菌的耐药性监测研究 

Public title:

Antimicrobial susceptibility of community-acquired respiratory tract pathogens isolated from adults in China  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国成人社区下呼吸道感染中肺炎链球菌、流感嗜血杆菌和卡他莫拉菌的耐药性监测研究(CARTIPS) 

Scientific title:

Antimicrobial susceptibility of community-acquired respiratory tract pathogens isolated from adults in China  

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:

刘雅 

研究负责人:

康梅 

Applicant:

Ya Liu 

Study leader:

Mei Kang 

申请注册联系人电话:

Applicant telephone:

+86 15882445616 

研究负责人电话:

Study leader's telephone:

+86 18980601892 

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:

408720660@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

kangmei@sina.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:

四川省成都市武侯区国学巷37号 

研究负责人通讯地址:

四川省成都市武侯区国学巷37号 

Applicant address:

37 Guoxeu Lane, Chengdu, Sichuan, China  

Study leader's address:

37 Guoxeu Lane, Chengdu, Sichuan, 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:

四川大学华西医院实验医学科 

Applicant's institution:

Laboratory Medicine Department, West China Hospital, Sichuan 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:

2018年审(500)号 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

四川大学华西医院生物医学伦理委员会 

Name of the ethic committee:

Biomedical Research Ethics Committee of West China Hospital of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-11 

伦理委员会联系人:

李娜 

Contact Name of the ethic committee:

Na Li 

伦理委员会联系地址:

四川省成都市武侯区国学巷37号 

Contact Address of the ethic committee:

37 Guoxeu Lane, Chengdu, Sichuan, 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:

北京大学人民医院 

Primary sponsor:

Peking university people's hospital 

研究实施负责(组长)单位地址:

北京市西直门南大街11号 

Primary sponsor's address:

1 South1 Xizhimen Street, Xicheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

拜耳医药保健有限公司 

Source(s) of funding:

Bayer 

研究疾病:

抗生素耐药 

Target disease:

drug-resistance 

研究疾病代码:

 

Target disease code:

 

研究类型:

流行病学研究 

Study type:

Epidemilogical research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

监测中国成人社区获得性下呼吸道感染病原菌肺炎链球菌、流感嗜血杆菌和卡他莫拉菌的耐药性(Community-Acquired Respiratory Tract Infection Pathogen Surveillance CARTIPS),并积累流行病学资料。 

Objectives of Study:

To monitor the drug-resistance rates of community-acquired respiratory tract pathogens isolated from adults in china and accumulate the epidemiological data  

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:

患者年龄≥18岁 社区获得性下呼吸道感染类型: 社区获得性肺炎 慢性支气管炎/慢性阻塞性肺病急性发作 呼吸道感染标本的来源: 血培养 痰培养(革兰染色确定为合格标本) 保护性毛刷培养 肺泡灌洗液培养 胸腔积液 气管吸取物 呼吸道组织 脑脊液 

Inclusion criteria

1. Aged >= 18 years; 2. Types of community-acquired lower respiratory tract infections, CAP/COPD at acute stage; 3. Source of respiratory infection specimens: Blood Culture, sputum culture, Protective brush culture, Broncho-Alveolar Lavage, Pleural fluid, Respiratory tissue, Cerebrospinal fluid. 

排除标准:

同一病人重复分离株 非致病菌(定植菌) 来自不合格痰标本的菌株,即痰涂片革兰染色证明有上呼吸道菌群污染 研究者考虑不合格的菌株 

Exclusion criteria:

1. Repeat the separation strain in the same patient; 2. Bacteriopexia; 3. unqualified stamps for polluted by Gram Staining proved; 4. investigator considered unqualified strain. 

研究实施时间:

Study execute time:

From2019-01-11To 2019-11-30 

干预措施:

Interventions:

组别:

Case series

样本量:

1400

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:

测量指标:

Outcomes:

指标中文名:

最低抑菌浓度

指标类型:

主要指标 

Outcome:

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:

组织:

Sample Name:

sputum

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 NA 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):

NA

盲法:

不适用

Blinding:

NA

原始数据公开时间:

The time of sharing IPD:

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):

文章发表

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

Publish an article

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-08-09
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