今天是:2019-07-21 星期日

β内酰胺类药物过敏诊断流程体系的建立
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注册号:

Registration number:

ChiCTR1900021051 

最近更新日期:

Date of Last Refreshed on:

2019-01-26 

注册时间:

Date of Registration:

2019-01-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

β内酰胺类药物过敏诊断流程体系的建立 

Public title:

The Allergy Diagnosis Protocol of β Lactam Drugs 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

β内酰胺类药物过敏诊断流程体系的建立 

Scientific title:

The Allergy Diagnosis Protocol of β Lactam Drugs 

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:

孟娟 

研究负责人:

孟娟 

Applicant:

Meng Juan 

Study leader:

Meng Juan 

申请注册联系人电话:

Applicant telephone:

+86 18980606505 

研究负责人电话:

Study leader's telephone:

+86 18980606505 

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:

Mjmelinda@163.com 

研究负责人电子邮件:

Study leader's E-mail:

Mjmelinda@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:

四川省成都市国学巷37号 

研究负责人通讯地址:

四川省成都市国学巷37号 

Applicant address:

37 Guoxue Lane, Wuhou District, Chengdu,Sichuan, China 

Study leader's address:

37 Guoxue Lane, Wuhou District, 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:

四川大学华西医院耳鼻咽喉头颈外科 

Applicant's institution:

Department of Otolaryngology, West China Hospital, Sichuan University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

四川大学华西医院耳鼻咽喉头颈外科 

Primary sponsor:

Department of Otolaryngology, West China Hospital, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市国学巷37号 

Primary sponsor's address:

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

单位(医院):

华西医院

具体地址:

成都市国学巷37号

Institution
hospital:

West China Hospital

Address:

No.37 GuoXue Xiang, Chengdu

经费或物资来源:

四川大学华西医院 

Source(s) of funding:

West China Hospital,Sichuan University 

研究疾病:

β内酰胺类药物过敏 

Target disease:

β Lactam Drugs 

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:

初步了解中国人群β内酰胺类药物过敏流行病学资料,为进一步开展全国多中心流调做准备;本研究的结果及相关数据将为β内酰胺类药物皮试方法的规范化、β内酰胺类药物过敏诊断检测流程规范等相关指南的制定提供重要依据。 

Objectives of Study:

This research is designed to collect the epidemiological statistics of β lactam drug allergy in Chinese population and it is a pilot study of the thorough epidemiological investigation nationwide. The outcome of this study will serve as evidence for making a standard skin test and diagnosis protocol of drug allergy to β lactam antibiotics. 

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. 华西医院HIS系统中2017年8月至2018年8月主诉β内酰胺类药物过敏的住院患者; 2. 年龄18-60岁,性别不限; 3. 签署知情同意书。 

Inclusion criteria

1. Inpatients with a complaint of drug allergy to β lactam antibiotics in West China Hospital from August 2017 to August 2018; 2. Aged 18 to 60 years, male or female; 3. Patients must sign the informed consent. 

排除标准:

1. 严重心脏疾病患者; 2. 哮喘未控制患者(FEV1<70%); 3. 高血压,正在使用β受体阻滞剂和/或ACEI的患者; 4. 病史提示为重度迟发过敏反应患者(反应发生在给药后1小时甚至数天,临床表现为Stevens-Johnson综合症、毒性上皮坏死溶解、剥脱性皮炎、DRESS综合症); 5. 严重精神疾病患者; 6. 在最近10年内发生过青霉素皮试、接触或者使用后发生过敏性休克的患者。 

Exclusion criteria:

1. Severe heart disease; 2. Uncontrolled asthma (FEV1<70%); 3. Hypertension patients taking β receptor blocker and/or ACEI; 4. Patients history indicates severe delayed allergic reaction. Allergy happens 1 hour later or even several days after having medicine, including Stevens-Johnson syndrome, toxic epithelial necrolysis, exfoliative dermatitis and DRESS syndrome; 5. Psychological disorder; 6. Patients experienced allergic shock after using penicillin or having a skin test of penicillin within 10 years. 

研究实施时间:

Study execute time:

From2019-03-01To 2024-01-01 

干预措施:

Interventions:

组别:

Case Series

样本量:

100

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):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

华西医院 

单位级别:

三级甲等 

Institution
hospital:

West China Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

血清特异性IgE

指标类型:

主要指标 

Outcome:

serum specific IgE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤点刺试验

指标类型:

主要指标 

Outcome:

skin prick test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮内试验

指标类型:

主要指标 

Outcome:

intradermal test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

口服药物试验

指标类型:

主要指标 

Outcome:

oral challenge test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

嗜碱性粒细胞活化试验

指标类型:

主要指标 

Outcome:

basophil activation test

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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

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):

试验完成后6个月内,通过网络平台www.medresman.org

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

We will share our data via www.medresman.org after the completing the this study in 6 months.

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:

数据采集和管理使用纸质版病例记录表和Resman

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

We plan to use physical CRF and EDC to collect and manage data.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-26
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