中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600124367
最近更新日期： Date of Last Refreshed on：	2026-05-11 16:07:17
注册时间： Date of Registration：	2026-05-11 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	人体免疫基态调控抗体翻译后修饰及效应功能的机制研究
Public title：	Mechanisms of Immune Homeostasis in Regulating Post-translational Modifications and Effector Functions of Antibodies
注册题目简写：
English Acronym：
研究课题的正式科学名称：	人体免疫基态调控抗体翻译后修饰及效应功能的机制研究
Scientific title：	Mechanisms of Immune Homeostasis in Regulating Post-translational Modifications and Effector Functions of Antibodies
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：	李嘉顺	研究负责人：	李嘉顺
Applicant：	Li jiashun	Study leader：	Li jiashun
申请注册联系人电话： Applicant telephone：	+86 13725363282	研究负责人电话： Study leader's telephone：	+86 20 6293 5357
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：	jiashun_lee@163.com	研究负责人电子邮件： Study leader's E-mail：	jiashun_lee@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：	广东省广州市花都区新华路48号	研究负责人通讯地址：	广州市花都区新华街新华路48号
Applicant address：	No. 48 Xinhua Road, Hua Du District, Guangzhou City, Guangdong Province, China	Study leader's address：	No. 48 Xinhua Road, Hua Du District, Guangzhou City, Guangdong Province, 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：	广州市花都区人民医院
Applicant's institution：	Huadu District Peoples Hospital of Guangzhou
研究负责人所在单位：	广州市花都区人民医院
Affiliation of the Leader：	Huadu District Peoples Hospital of Guangzhou

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：	批件（2026）-0110	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	广州市花都区人民医院临床试验伦理委员会
Name of the ethic committee：	Clinical Trial Ethics Committee of Guangzhou Huadu District People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2026-05-07 00:00:00
伦理委员会联系人：	张晓尉
Contact Name of the ethic committee：	Zhang XiaoWei
伦理委员会联系地址：	广州市花都区新华街新华路48号
Contact Address of the ethic committee：	No. 48 Xinhua Road, Hua Du District, Guangzhou City, Guangdong Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 20 62935296	伦理委员会联系人邮箱： Contact email of the ethic committee：	20xwzhang1@alumni.stu.edu.cn

研究实施负责（组长）单位：

广州市花都区人民医院

Primary sponsor：

Huadu District Peoples Hospital of Guangzhou

研究实施负责（组长）单位地址：

广州市花都区新华街新华路48号

Primary sponsor's address：

No. 48 Xinhua Road, Hua Du District, Guangzhou City, Guangdong Province, 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)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广州市花都区人民医院	具体地址：	广州市花都区新华街新华路48号
Institution hospital：	Huadu District Peoples Hospital of Guangzhou	Address：	No. 48 Xinhua Road, Hua Du District, Guangzhou City, Guangdong Province, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-funded Project

研究疾病：

社区获得性肺炎

Target disease：

Community-acquired pneumonia (CAP)

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

病例对照研究

Study design：

Case-Control study

研究目的：

1. 探索不同年龄层非病毒、非细菌感染研究参与者在基础免疫状态下抗体翻译后修饰的特征，揭示其是否存在系统性差异； 2. 分析抗体翻译后修饰的改变如何影响其介导的病毒、细菌清除能力，并探讨这些修饰特征与病毒及细菌感染后疾病严重程度的关联； 3. 探究机体在病毒和细菌感染前的基础免疫状态是否影响后续感染中抗体翻译后修饰的模式及其免疫功能表现； 4. 从抗体翻译后修饰的角度，为部分人群易发展为重症感染提供机制解释，并为针对性的免疫干预策略提供参考。

Objectives of Study：

1. To elucidate the characteristics of antibody post-translational modifications in the baseline immune state of non-infected study participants across different age groups, and to reveal whether systematic differences exist. 2. To analyze how alterations in antibody post-translational modifications affect their ability to mediate the clearance of viruses and bacteria, and to explore the association between these modification profiles and the severity of disease following viral or bacterial infection. 3. To investigate whether the host's baseline immune state prior to infection influences the patterns of antibody post-translational modifications and their resultant immune functions during subsequent viral or bacterial infections. 4. To provide a mechanistic explanation, from the perspective of antibody post-translational modifications, for the susceptibility of certain populations to developing severe infections, and to offer insights for developing targeted immunomodulatory strategies.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Inclusion Criteria for the Viral or Bacterial Pneumonia Patient Group  
   Patients who meet all of the following criteria are eligible for inclusion in the study:  
   (1) Diagnosed with community-acquired pneumonia (CAP) of viral or bacterial etiology according to the diagnostic criteria outlined in the Clinical Practice Guideline for Emergency Adult Community-Acquired Pneumonia (2024 Edition).  
   (2) Aged between 18 and 75 years.  
   (3) Time since symptom onset is within 72 hours.  
   (4) Has provided written informed consent and voluntarily agrees to participate in the study.

2. Inclusion Criteria for the Non-infected Study Participant Group  
   Individuals who meet all of the following criteria are eligible for inclusion in the study:  
   (1) Aged between 18 and 75 years.  
   (2) No acute infectious diseases (including, but not limited to, respiratory, gastrointestinal, or urinary tract infections) within the past 4 weeks.  
   (3) No known chronic active inflammatory diseases or autoimmune diseases.  
   (4) No recent vaccination (e.g., within the past 3 months), or a clear vaccination history without significant adverse reactions (further specification can be applied if needed).  
   (5) Assessed by the investigator as being in generally stable condition and able to comply with the study procedures.  
   (6) Capable of understanding the study content, voluntarily agrees to participate, and provides written informed consent.  
   (7) Scheduled to undergo bronchoscopy for clinical reasons (e.g., pulmonary nodules), with the decision regarding lavage made clinically, and agrees to the use of any residual Bronchoalveolar Lavage Fluid (BALF) remaining after clinical testing/treatment (if available).

排除标准：

符合以下任一条件的患者，应予以排除： 1. 其他肺部疾病干扰评估：活动性肺结核、肺纤维化、肺癌、肺脓肿、非感染性间质性肺病、肺栓塞等；需要立即处理的危及生命的非肺炎性肺部疾病。 2. 严重基础疾病或合并症： (1) 存在严重的免疫缺陷疾病（如活动期艾滋病、白血病、中性粒细胞缺乏症等），或正在接受大剂量免疫抑制剂治疗（如化疗、器官移植后抗排异治疗，长期口服激素剂量相当于泼尼松 >= 20 mg/日持续 2 周以上）； (2) 严重的肝功能障碍（如 Child-Pugh 分级 C 级或急性肝衰竭）； (3) 严重的肾功能不全（肾小球滤过率 < 30 mL/min/1.73 m^2 或接受肾脏替代治疗）； (4) 纽约心脏病协会心功能分级 III-IV 级的充血性心力衰竭； (5) 无法控制的心律失常或近 6 个月内有急性心肌梗死病史； (6) 预计生存期少于 3 个月的晚期恶性肿瘤患者。 3. 研究相关治疗与暴露： (1) 入院前 72 小时内已接受系统性（口服或静脉）有效抗菌药物治疗超过 24 小时； (2) 已知或高度怀疑对研究方案中拟使用的抗菌药物及其辅料存在严重过敏史。 4. 特殊情况： (1) 妊娠或哺乳期妇女； (2) 存在可能显著影响药物吸收、分布、代谢或排泄的胃肠道疾病（如活动性溃疡性结肠炎、肠梗阻等）； (3) 存在精神疾病、认知障碍或任何其他原因，导致无法理解研究内容、无法配合完成治疗方案及随访要求； (4) 研究者认为存在任何其他不适合参与本研究的医学或社会心理因素。

Exclusion criteria：

Patients meeting any of the following criteria should be excluded: 1. Other pulmonary diseases interfering with assessment: active tuberculosis, pulmonary fibrosis, lung cancer, lung abscess, non-infectious interstitial lung disease, pulmonary embolism, etc.; life-threatening non-pneumonia pulmonary diseases requiring immediate intervention. 2. Severe underlying diseases or comorbidities: (1) Presence of severe immunodeficiency diseases (such as active AIDS, leukemia, neutropenia, etc.), or currently receiving high-dose immunosuppressive therapy (such as chemotherapy, post-organ transplant anti-rejection therapy, long-term oral corticosteroid doses equivalent to prednisone >= 20 mg/day for more than 2 weeks); (2) Severe liver dysfunction (such as Child-Pugh class C or acute liver failure); (3) Severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m^2 or receiving renal replacement therapy); (4) Congestive heart failure with New York Heart Association (NYHA) functional class III-IV; (5) Uncontrolled arrhythmia or history of acute myocardial infarction within the past 6 months; (6) Patients with advanced malignant tumors with an expected survival of less than 3 months. 3. Study-related treatment and exposures: (1) Systemic (oral or intravenous) effective antibacterial therapy for more than 24 hours within 72 hours prior to admission; (2) Known or highly suspected severe allergy to antibacterial drugs and their excipients intended for use in the study protocol. 4. Special circumstances: (1) Pregnant or breastfeeding women; (2) Gastrointestinal diseases that may significantly affect drug absorption, distribution, metabolism, or excretion (such as active ulcerative colitis, intestinal obstruction, etc.); (3) Presence of mental illness, cognitive impairment, or any other reason that prevents understanding of the study, compliance with the treatment regimen, and follow-up requirements; (4) Any other medical or psychosocial factors that the investigator deems unsuitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-04-13 00:00:00至 To 2029-03-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-13 00:00:00 至 To 2028-12-31 00:00:00

干预措施：

Interventions：

组别：	社区获得性肺炎组	样本量：	100
Group：	CAP group	Sample size：	100
干预措施：	无	干预措施代码：
Intervention：	none	Intervention code：

组别：	非感染组	样本量：	50
Group：	Non-infected group	Sample size：	50
干预措施：	无	干预措施代码：
Intervention：	none	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	广州市花都区人民医院	单位级别：	三级甲等
Institution hospital：	Huadu District Peoples Hospital of Guangzhou	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	抗体分子结构及其翻译后修饰特征	指标类型：	主要指标
Outcome：	General Characteristics of Antibody Molecular Structure and Its Post-translational Modification Patterns	Type：	Primary indicator
测量时间点：	确诊社区获得性肺炎后24-72h内	测量方法：	质谱分析、生物信息学、酶学分析
Measure time point of outcome：	Within 24-72 hours of confirmed community-acquired pneumonia (CAP) diagnosis	Measure method：	Mass spectrometric analysis/Bioinformatics/Enzymatic analysis

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	肺泡灌洗液	组织：
Sample Name：	Bronchoalveolar lavage fluid (BALF)	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

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：

标本中文名：	粪便	组织：
Sample Name：	Feces	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	岁 years
最大 Max age	75	岁 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）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	否No
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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	none
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：	通过病历记录表（CRF）采集数据，研究者汇总、分析数据。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data will be collected via case report forms (CRFs) and subsequently collated and analyzed by the investigators.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2026-05-11 16:07:07