A Study of the Mechanisms of Infection Susceptibility Across the Life Course and the Development of an Intelligent Prevention and Control System
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.
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Jingwen Dr Ai
- Número de telefone: 86+13764990804
- E-mail: jingwenai1990@126.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Adults aged 18 years and older
Descrição
Inclusion Criteria:
- Aged 18 years or older and undergoing an adult health examination or health screening at a participating center.
- No severe organ dysfunction that substantially affects daily living, such as decompensated heart, liver, or kidney failure.
- Able to communicate and cooperate with study procedures.
- Willing to participate and provides informed consent in accordance with ethics committee-approved requirements.
Exclusion Criteria:
- Declines to participate.
- Essential clinical information required for the study is unavailable and cannot be obtained after verification.
- Considered unsuitable for participation by the investigator; the specific reason will be documented.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of the Composite Endpoint of Death or Severe Infection
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Overall Infection
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From baseline to Year 5
|
Proportion of peripheral blood immune cell subsets with Infection Susceptibility and Severity |
From baseline to Year 5
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KY2026-
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .