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注册号: Registration number: |
ChiCTR2500114141 |
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最近更新日期: Date of Last Refreshed on: |
2025-12-08 12:23:02 |
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注册时间: Date of Registration: |
2025-12-08 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
慢阻肺急性加重病原学流行病学调查及预后分析 |
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Public title: |
Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Pathogen Epidemiology Investigation and Prognostic Analysis (Chapter COPD) |
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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: |
慢阻肺急性加重病原学流行病学调查及预后分析 |
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Scientific title: |
Acute Exacerbation of Chronic Obstructive Pulmonary Disease: Pathogen Epidemiology Investigation and Prognostic Analysis (Chapter COPD) |
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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: |
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申请注册联系人: |
张静 |
研究负责人: |
张静 |
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Applicant: |
Zhang Jing |
Study leader: |
Zhang Jing |
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申请注册联系人电话: Applicant telephone: |
+86 186 1688 1189 |
研究负责人电话:
Study leader's |
+86 186 1688 1189 |
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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: |
zhang.jing@zs-hospital.sh.cn |
研究负责人电子邮件: Study leader's E-mail: |
zhang.jing@zs-hospital.sh.cn |
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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: |
上海市徐汇区枫林路180号 |
研究负责人通讯地址: |
上海市徐汇区枫林路180号 |
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Applicant address: |
No. 180, Fenglin Road, Xuhui District, Shanghai |
Study leader's address: |
No. 180, Fenglin Road, Xuhui District, Shanghai |
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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: |
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申请人所在单位: |
复旦大学附属中山医院 |
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Applicant's institution: |
Zhongshan Hospital, Fudan University |
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研究负责人所在单位: |
复旦大学附属中山医院 |
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Affiliation of the Leader: |
Zhongshan Hospital, Fudan University |
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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: |
B2025-639R |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
复旦大学附属中山医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Zhongshan Hospital, Fudan University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-11-04 00:00:00 | ||
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伦理委员会联系人: |
杨梦婕 |
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Contact Name of the ethic committee: |
Yang Mengjie |
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伦理委员会联系地址: |
上海市徐汇区枫林路180号 |
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Contact Address of the ethic committee: |
No. 180, Fenglin Road, Xuhui District, Shanghai |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 21 3158 7871 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
ec@zs-hospital.sh.cn |
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研究实施负责(组长)单位: |
复旦大学附属中山医院 |
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Primary sponsor: |
Zhongshan Hospital, Fudan University |
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研究实施负责(组长)单位地址: |
上海市徐汇区枫林路180号 |
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Primary sponsor's address: |
No. 180, Fenglin Road, Xuhui District, Shanghai |
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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: |
中国人体健康科技促进会 |
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Source(s) of funding: |
China Association for Promotion of Health Science and Technology |
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研究疾病: |
慢性阻塞性肺疾病 |
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Target disease: |
Chronic Obstructive Pulmonary Disease |
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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: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
系统掌握我国AECOPD的病原体构成谱和主要致病菌的耐药特点。在AECOPD病程中曲霉检出阳性的患者群体,分析其疾病状态及不同治疗手段对疾病近期和远期预后的影响。 |
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Objectives of Study: |
In order to systematically grasp the pathogen composition profile of AECOPD in our country and the drug resistance characteristics of the main pathogens. To analyze the effect of disease status and different treatment methods on the short-term and long-term prognosis of AECOPD patients with Aspergillus positive detection. |
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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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纳入标准: |
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Inclusion criteria |
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排除标准: |
1) 合并特发性肺间质纤维化、CTD-ILD等间质性肺疾病者; 2) 经过初步临床评估和检查,判断症状恶化主要是肺炎、肺栓塞、气胸、心功能不全等其他急性病况所致; 3) 精神异常无法完成研究。 |
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Exclusion criteria: |
1) Patients with idiopathic pulmonary interstitial fibrosis, CTD-ILD and other interstitial lung diseases; 2) After preliminary clinical evaluation and examination, it is determined that the worsening of symptoms is mainly caused by other acute conditions such as pneumonia, pulmonary embolism, pneumothorax, and cardiac insufficiency; 3) Mental abnormality that prevents completion of the study. |
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研究实施时间: Study execute time: |
从 From 2025-12-01 00:00:00至 To 2027-11-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-12-10 00:00:00 至 To 2027-11-30 00:00:00 |
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干预措施: Interventions: |
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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: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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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): |
队列研究,根据患者病原学检测结果进行分组分析。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Cohort study, group analysis based on patient etiology test results. |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
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Blinding: |
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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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是否共享原始数据: IPD sharing |
是Yes |
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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): |
学术论文发表 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Academic papers published |
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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: |
各中心收集资料,根据CRF表将数据录入EDC系统生成一个数据库,后续人工核查完成校对。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Each center collects data, enters the data into the EDC system according to the CRF form to generate a database, and then manually verifies and completes proofreading. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |