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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jingwen Dr Ai
- Número de teléfono: 86+13764990804
- Correo electrónico: jingwenai1990@126.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adults aged 18 years and older
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of the Composite Endpoint of Death or Severe Infection
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Overall Infection
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY2026-
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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