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斑贴试验在诊断迟发型变态反应型药疹中的临床应用研究
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注册号:

Registration number:

ChiCTR-DPD-14005254 

最近更新日期:

Date of Last Refreshed on:

2014-09-25 

注册时间:

Date of Registration:

2014-07-16 

注册号状态:

 

Registration Status:

 

注册题目:

斑贴试验在诊断迟发型变态反应型药疹中的临床应用研究 

Public title:

Patch Tests for Diagnosing Cutaneous Delayed Hypersensitivity Reactions to Drugs 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

斑贴试验在诊断迟发型变态反应型药疹中的临床应用研究 

Scientific title:

Patch Tests for Diagnosing Cutaneous Delayed Hypersensitivity Reactions to 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:

孙晨 

研究负责人:

王华 

Applicant:

Chen Sun 

Study leader:

Hua Wang 

申请注册联系人电话:

Applicant telephone:

+86 15123329290 

研究负责人电话:

Study leader's telephone:

+86 15123380348 

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:

sunchen841@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

huawang63@hotmail.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:

重庆市渝中区中山二路136号重庆医科大学附属儿童医院皮肤科 

研究负责人通讯地址:

重庆市渝中区中山二路136号重庆医科大学附属儿童医院皮肤科 

Applicant address:

Dermotology Department,Children's Hospital of Chongqing Medical University, NO.136, Zhongshaner Road 

Study leader's address:

Dermotology Department,Children's Hospital of Chongqing Medical University, NO.136, Zhongshaner Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400014 

研究负责人邮政编码:

Study leader's postcode:

400014 

申请人所在单位:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing Medical Universit 

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:

009/2012 

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:

重庆医科大学附属儿童医院伦理委员会 

Name of the ethic committee:

Institutional Review Board Children's Hospital Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-03-05 

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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号重庆医科大学附属儿童医院皮肤科 

Primary sponsor's address:

Dermatology Department, Children's Hospital of Chongqing Medical University, 136 Zhongshaner Road, Yuzhong District, Chongqing, 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):

重庆

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

重庆市卫生局

具体地址:

重庆市渝北区松石北路418号

Institution
hospital:

Chongqing Health Bureau

Address:

NO.418, Songshi North Road, Yubei District, Chongq

经费或物资来源:

重庆市卫生局医学科研项目重点项目 

Source(s) of funding:

Key project of medical research of Chongqing Health Bureau 

研究疾病:

迟发型变态反应型药疹 

Target disease:

Cutaneous Delayed Hypersensitivity Reactions to Drugs 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

(1)了解PT诊断儿童迟发型变态反应型药疹的可行性、安全性、准确性及其应用价值。 (2)探索诊治迟发型变态反应型药疹的临床路径,为今后的临床工作提供规范化的诊治流程。 

Objectives of Study:

(1)To investigate the feasibility,security,accuracy and application value of patch tests in diagnosing cutaneous delayed hypersensitivity reactions to drugs in children; (2)To discuss the general procedures of diagnosis and treatment of cutaneous delayed hypersensitivity reactions to drugs. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

A:(1)对受试药物耐受的健康人;(2)年龄:0-18岁;(3)自愿参加本研究 B:(1)药疹完全治愈后6周至6个月内;(2)患者年龄:0-18岁;(3)自愿参加本研究 

Inclusion criteria

A:(1)Healthy individuals who are tolerant to the tested drugs;(2)Age:0~18;(3)Healthy individuals who are willing to enroll in the trial. B:(1)6 weeks to 6 months after complete healing of cutaneous delayed hypersensitivity reactions to drugs;(2) Age:0~18;(3) Patients who are willing to enroll in the trial. 

排除标准:

A:(1)有过敏性疾病病史者,如食物过敏、特应性皮炎、过敏性鼻炎、哮喘等;(2)3天内用过抗组胺药,1月内使用过激素或免疫抑制剂 B:(1)重症药疹的患者,如史-约综合征、中毒性表皮坏死松解症、急性泛发型发疹性脓疱病等;(2)3天内用过抗组胺药,1月内使用过激素或免疫抑制剂;(3)伴有严重心肝肾功能不全患者 

Exclusion criteria:

A:(1)Healthy individuals with a history of allergic disease,e.g.food allergy,atopic dermatitis,allergic rhinitis or asthma;(2)Healthy individuals who are treated with antihistamines within 3 days and/or corticosteroid/immunosuppressive agents within 1 month. B:(1)Patients who have experienced severe,life-threatening cutaneous delayed hypersensitivity reactions to drugs,e.g.Stevens-Johnson syndrome,toxic epidermal necrolysis,acute generalized exanthematous pustulosis.(2)Patients who are treated with antihistamines within 3 days and/or corticosteroid/immunosuppressive agents within 1 month.(3)Patients with severe cardiac,liver or renal dysfunction. 

研究实施时间:

Study execute time:

From2014-08-01To 2015-05-30 

征募观察对象时间:

Recruiting time:

From2014-08-01To  

诊断试验:

Diagnostic Tests:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

Index test:

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

例数:

Sample size:

0

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

例数:

Sample size:

0

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等 

Institution
hospital:

Children's hospital of Chongqing Medical Universit  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

斑贴试验诊断准确性

指标类型:

主要指标 

Outcome:

Diagnostic accuracy of patch tests for diagnosing

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

Gender:

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:

No

Blinding:

No

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):

重庆医科大学附属儿童医院

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

Childrens Hospital of Chongqing Medical University

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:

重庆医科大学附属儿童医院

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

Childrens Hospital of Chongqing Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-07-16
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