- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07644962
Research Project on the Interaction Between Immune Function and Infectious Diseases in Older Adults and the Development of Prevention and Control Strategies
As population aging accelerates, infectious diseases have become a major factor affecting the health, quality of life, and survival outcomes of older adults. Immunosenescence, chronic low-grade inflammation (inflammaging), and dysbiosis of the respiratory and gut microbiota are considered important mechanisms underlying increased susceptibility to infection and a higher risk of severe disease in older adults. However, the interactions among these factors and their impact on infection-related outcomes remain incompletely understood.
Building upon a previously established pilot cohort of older adults, this study aims to further identify and validate key biological characteristics and risk factors associated with infectious diseases through large-scale population follow-up. A large prospective cohort of older adults will be established, while retrospective healthcare data collected since 2019 will also be integrated. Demographic information, comorbidities, medication history, infection-related clinical data, and biological specimens, including blood, urine, fecal, and respiratory samples, will be collected for long-term longitudinal follow-up. By integrating immunological assessments, immune repertoire analyses, microbiome profiling, and other multi-omics technologies, this study will systematically evaluate the effects of immunosenescence, respiratory and gut microbiome alterations, and environmental and climatic factors on the occurrence, severity, and prognosis of infectious diseases in older adults. The study aims to identify key biomarkers and microbial signatures associated with infection risk and to develop risk prediction and early warning models for infectious diseases in older adults, thereby providing scientific evidence for precision prevention, optimized clinical management, and public health decision-making in aging populations.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jingwen Ai
- Número de teléfono: 17317958269
- Correo electrónico: jingwenai1990@126.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- General Cohort Inclusion Criteria
- Adults aged 60 years or older who are in generally good health, defined as having no severe organ dysfunction that significantly affects daily living activities (e.g., decompensated heart, liver, or kidney failure), adequate nutritional status (without significant wasting or malnutrition), and the ability to communicate and comply with study procedures.
- Male or female.
- Able to understand the study and voluntarily provide written informed consent.
Infection Cohort Inclusion Criteria
- Adults aged 60 years or older, regardless of sex.
- Patients with an infectious disease diagnosed by a qualified clinician.
Exclusion Criteria:
General Cohort Exclusion Criteria
- Refusal to participate in this study.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
Infection Cohort Exclusion Criteria
- Final primary diagnosis is a non-infectious disease (e.g., connective tissue disease, malignancy, or other non-infectious conditions).
- Positive culture results determined by the treating clinician to represent colonization or contamination rather than true infection.
- Refusal to participate in this study.
- Critically ill patients or those unable to cooperate with specimen collection procedures.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Older Adults Without Infection
Community-dwelling adults aged 60 years and older who do not develop any clinically diagnosed infectious disease during the follow-up period.
|
|
Older Adults With Infection
Community-dwelling adults aged 60 years and older who develop clinically diagnosed infectious diseases during follow-up.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Occurrence of infectious disease outcomes in older adults
Periodo de tiempo: Baseline to 3 years
|
Occurrence of infectious disease outcomes in older adults, including all-cause mortality, infection-related mortality, first infectious disease event, and progression to severe infection.
|
Baseline to 3 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
High-Frequency Infection Status (≥6 Infections per Year)
Periodo de tiempo: Baseline to 3 Years
|
Defined as an average of six or more infectious episodes per year during follow-up.
|
Baseline to 3 Years
|
|
Pathogen-Specific Infection Events
Periodo de tiempo: Baseline to 3 Years
|
Infectious disease events caused by specific pathogens, used to evaluate pathogen distribution and temporal trends.
|
Baseline to 3 Years
|
|
Changes in Immune Function Biomarkers
Periodo de tiempo: Baseline to 3 Years
|
Assessment of longitudinal changes in immune cell subsets and immune function status.
|
Baseline to 3 Years
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in Metabolomic and Microbiome Profiles
Periodo de tiempo: Baseline to 3 Years
|
Assessment of longitudinal changes in metabolomic profiles and gut and respiratory microbiome characteristics associated with infection risk and disease severity.
|
Baseline to 3 Years
|
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
- 20260306-001
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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