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: |
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Registration Status: |
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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: |
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English Acronym: |
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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: |
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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: |
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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): |
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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 |
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Applicant's institution: |
Children's Hospital of Chongqing Medical Universit |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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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: |
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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 |
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Name of the ethic committee: |
Institutional Review Board Children's Hospital Chongqing Medical University |
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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: |
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Contact Name of the ethic committee: |
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伦理委员会联系地址: |
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Contact Address of the ethic committee: |
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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 |
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Primary sponsor: |
Children's Hospital of Chongqing Medical University |
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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 |
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Primary sponsor's address: |
Dermatology Department, Children's Hospital of Chongqing Medical University, 136 Zhongshaner Road, Yuzhong District, Chongqing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
重庆市卫生局医学科研项目重点项目 |
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Source(s) of funding: |
Key project of medical research of Chongqing Health Bureau |
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研究疾病: |
迟发型变态反应型药疹 |
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Target disease: |
Cutaneous Delayed Hypersensitivity Reactions to Drugs |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
诊断试验 |
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Study type: |
Diagnostic test |
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研究所处阶段: |
I期临床试验 | ||||||||||||||||||||||
Study phase: |
1 |
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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。 |
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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. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
诊断试验诊断准确性 |
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Study design: |
Diagnostic test for accuracy |
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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 |
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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. |
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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 |
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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: |
从From2014-08-01至To 2015-05-30 |
征募观察对象时间: Recruiting time: |
从From2014-08-01至To |
诊断试验: Diagnostic Tests: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
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Gender: |
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随机方法(请说明由何人用什么方法产生随机序列): |
N/A |
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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): |
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Calculated Results after
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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 |