Research Project on the Interaction Between Immune Function and Infectious Diseases in Older Adults and the Development of Prevention and Control Strategies

NCT07644962 | Not Yet Recruiting

• 1 other identifier: 20260306-001
• Study Type: observational
• Target: 23,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infectious Diseases; Immunosenescence; Aging

Outcome Measures

Primary Outcomes (1)

• Occurrence of infectious disease outcomes in older adults

  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

Secondary Outcomes (3)

• High-Frequency Infection Status (≥6 Infections per Year)

  Baseline to 3 Years

• Pathogen-Specific Infection Events

  Baseline to 3 Years

• Changes in Immune Function Biomarkers

  Baseline to 3 Years

Other Outcomes (1)

• Changes in Metabolomic and Microbiome Profiles

  Baseline to 3 Years

Study Arms (2)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults aged 60 years and older

You may qualify if:

• 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.
• Adults aged 60 years or older, regardless of sex.
• Patients with an infectious disease diagnosed by a qualified clinician.

You may not qualify if:

• Refusal to participate in this study.
• Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.
• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jingwen Ai

CONTACT

17317958269; jingwenai1990@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06