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A Study of the Mechanisms of Infection Susceptibility Across the Life Course and the Development of an Intelligent Prevention and Control System

2026年11月12日 更新者：Jingwen Ai、Huashan Hospital

This multicenter, observational registry study aims to characterize host immune, genetic, and microbiome features associated with susceptibility to infection and the risk of severe infection in adults. Approximately 2,195 adults aged 18 years or older undergoing routine health examinations or health screening will be enrolled and followed prospectively for five years. Available clinical information and previously stored biological samples collected since 2019 will also be retrospectively integrated. Demographic characteristics, medical history, medication use, vaccination history, laboratory findings, infection events, treatments, hospitalizations, intensive care admissions, and clinical outcomes will be recorded. Blood, urine, stool, sputum, and nasopharyngeal or oropharyngeal samples will be collected when available to evaluate host immune responses, genetic characteristics, biomarkers, and microbial composition and function. By integrating longitudinal clinical data with biological measurements, the study seeks to identify potential biomarkers and improve infection-risk prediction beyond conventional clinical factors, thereby supporting risk stratification and the development of personalized infection-prevention strategies.

研究概览

地位

尚未招聘

条件

研究类型

观察性的

注册 (估计的)

2195

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Adults aged 18 years and older

描述

Inclusion Criteria:

  1. Aged 18 years or older and undergoing an adult health examination or health screening at a participating center.
  2. No severe organ dysfunction that substantially affects daily living, such as decompensated heart, liver, or kidney failure.
  3. Able to communicate and cooperate with study procedures.
  4. Willing to participate and provides informed consent in accordance with ethics committee-approved requirements.

Exclusion Criteria:

  1. Declines to participate.
  2. Essential clinical information required for the study is unavailable and cannot be obtained after verification.
  3. Considered unsuitable for participation by the investigator; the specific reason will be documented.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：COHORT
  • 时间观点：PROSPECTIVE

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Number of the Composite Endpoint of Death or Severe Infection
大体时间：From baseline to Year 5

Number of participants experiencing at least one component of the composite endpoint: all-cause death, infection-related death, or severe infection. Severe infection will be evaluated based on clinically documented outcomes, including infection-related hospitalization, intensive care unit admission, mechanical ventilation, or other life-threatening infection events.
From baseline to Year 5

次要结果测量

结果测量
措施说明
大体时间
Incidence of Overall Infection
大体时间：From baseline to Year 5

Number and proportion of participants who experience at least one clinically documented infection, including respiratory tract infection, bloodstream infection, urinary tract infection, or another confirmed infectious disease.
From baseline to Year 5
Incidence of Respiratory Tract Infection
大体时间：From baseline to Year 5

Number and proportion of participants who experience at least one respiratory tract infection, including upper respiratory tract infection, bronchitis, pneumonia, or another respiratory infection confirmed by clinical diagnosis or pathogen testing.
From baseline to Year 5
Incidence of Bloodstream Infection
大体时间：From baseline to Year 5

Number and proportion of participants who experience at least one clinically documented bloodstream infection, including bacteremia, fungemia, or another bloodstream infection supported by blood culture or other pathogen testing in the presence of clinical signs of infection.
From baseline to Year 5
Incidence of Urinary Tract Infection
大体时间：From baseline to Year 5

Number and proportion of participants who experience at least one urinary tract infection, including cystitis, pyelonephritis, or another urinary tract infection supported by clinical diagnosis, urine pathogen testing, or documented anti-infective treatment.
From baseline to Year 5
Correlation Between Gut Microbiome Alpha Diversity and Infection Episode Rate
大体时间：From baseline to Year 5

Spearman's correlation coefficient (ρ) between baseline gut microbiome alpha diversity (Shannon index) measured from stool samples and infection episode rate (episodes/person-year) obtained from clinical records during follow-up.
From baseline to Year 5
Proportion of peripheral immune cell subset with Infection Susceptibility and Severity
大体时间：From baseline to Year 5

Proportion of peripheral blood immune cell subsets with Infection Susceptibility and Severity
From baseline to Year 5

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Huashan Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2032年12月31日

研究完成 (估计的)

2032年12月31日

研究注册日期

首次提交

2026年10月29日

首先提交符合 QC 标准的

2026年11月12日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月12日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • KY2026-

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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