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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2500111092 |
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最近更新日期: Date of Last Refreshed on: |
2025-10-24 17:24:37 |
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注册时间: Date of Registration: |
2025-10-24 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
全国急诊社区获得性肺炎病原学流行病学调查 |
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Public title: |
National etiological epidemiological Investigation of community-acquired Pneumonia in Emergency Departments |
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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: |
全国急诊社区获得性肺炎病原学流行病学调查 |
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Scientific title: |
National etiological epidemiological Investigation of community-acquired Pneumonia in Emergency Departments |
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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: |
张淑文 |
研究负责人: |
郭伟 |
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Applicant: |
Zhang Shuwen |
Study leader: |
Guo Wei |
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申请注册联系人电话: Applicant telephone: |
+86 178 8880 8638 |
研究负责人电话:
Study leader's |
+86 136 2128 9067 |
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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: |
zsw1412592751@163.com |
研究负责人电子邮件: Study leader's E-mail: |
Guowei1010@126.com |
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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: |
北京市东城区美术馆后街23号 |
研究负责人通讯地址: |
北京市东城区美术馆后街23号 |
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Applicant address: |
Dongcheng District, Beijing, 23 Back Street of Art Museum |
Study leader's address: |
Dongcheng District, Beijing, 23 Back Street of Art Museum |
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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: |
首都医科大学附属北京中医医院 |
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Applicant's institution: |
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University |
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研究负责人所在单位: |
首都医科大学附属北京中医医院 |
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Affiliation of the Leader: |
Beijing Hospital of Traditional Chinese Medicine, Capital Medical 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: |
2025BL02-063-03 |
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: |
首都医科大学附属北京中医医院医学伦理委员会 |
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Name of the ethic committee: |
Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-08-05 00:00:00 | ||
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伦理委员会联系人: |
刘声 |
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Contact Name of the ethic committee: |
Liu Sheng |
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伦理委员会联系地址: |
北京市东城区美术馆后街23号 |
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Contact Address of the ethic committee: |
Dongcheng District, Beijing, 23 Back Street of Art Museum |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 8790 6734 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
首都医科大学附属北京中医医院 |
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Primary sponsor: |
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University |
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研究实施负责(组长)单位地址: |
北京市东城区美术馆后街23号 |
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Primary sponsor's address: |
Dongcheng District, Beijing, 23 Back Street of Art Museum |
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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: |
国家中医药管理局高水平中医药重点学科建设 |
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Source(s) of funding: |
Key Discipline Development of High-Level Traditional Chinese Medicine under the National Administration of Traditional Chinese Medicine |
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研究疾病: |
社区获得性肺炎 |
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Target disease: |
Community-acquired pneumonia |
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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: |
横断面 |
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Study design: |
Cross-sectional |
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研究目的: |
本研究拟选取涵盖不同年龄、性别、职业、居住地和不同季节的急诊社区获得性肺炎病例,发现其年龄分布、性别分布、职业分布、居住地分布(城市、农 村等)、季节分布等特征,为临床经验性治疗提供病原学依据,提高急诊CAP的治疗效果,降低患者重症发生率和病死率,同时为制定针对性的防控措施提供科学依据。 |
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Objectives of Study: |
This study will enroll emergency-department patients with community-acquired pneumonia who are representative of diverse ages, sexes, occupations, places of residence, and seasons. By characterizing the age, sex, occupational, residential (urban vs. rural, etc.), and seasonal distributions of these cases, we aim to provide an etiological foundation for empirical clinical treatment, improve therapeutic outcomes for emergency CAP, reduce the incidence of severe illness and case-fatality rates, and furnish scientific evidence for the development of targeted prevention and control measures. |
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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: |
1.年龄>=18岁,符合社区获得性肺炎诊断标准; 2.急诊就诊患者; 3.入院后完善病原学检测且病原明确。 |
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Inclusion criteria |
1.Age >=18 years old, meeting the diagnostic criteria for community-acquired pneumonia; 2. Emergency patients; 3. After admission, complete the etiological test and ensure the pathogen is clear. |
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排除标准: |
1.免疫缺陷患者:如人类免疫缺陷病毒(HIV)/获得性免疫缺陷综合征(AIDS)患者、器官移植术后患者等; 2.慢性呼吸道疾病患者:如慢性阻塞性肺疾病(COPD)、支气管扩张等。 |
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Exclusion criteria: |
1. Patients with immune deficiencies: such as those with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS), patients after organ transplantation, etc. 2. Patients with chronic respiratory diseases: such as chronic obstructive pulmonary disease (COPD), bronchiectasis, etc. |
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研究实施时间: Study execute time: |
从 From 2025-08-01 00:00:00至 To 2027-06-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2025-08-01 00:00:00 至 To 2027-06-30 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: |
正在进行 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): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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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: |
无 |
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Blinding: |
None |
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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): |
研究结束后,通过ResMan(www.medresman.org.cn)方式共享 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
After the end of the study, it was shared by ResMan (www.medresman.org.cn). |
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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: |
病例记录表 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Case Record Form, CRF |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |