Exploratory Study on Infection and Immunosenescence Based on an Elderly Clinical Cohort

NCT07672522 | Recruiting

• 1 other identifier: KY2024-1177
• Study Type: observational
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective observational cohort study aims to investigate the relationship between immunosenescence and infectious diseases in older adults. Individuals aged 60 years and older, including elderly patients with infections and healthy controls, will be enrolled and followed longitudinally. Clinical information, laboratory test results, and health assessment data will be collected. Biological specimens, including peripheral blood, urine, stool, sputum, and nasopharyngeal swabs, will be obtained during enrollment and follow-up. Participants will undergo regular assessments of health status, infection events, and aging-related clinical characteristics. The study will evaluate age-related changes in immune function, immune cell composition, immune receptor repertoires, epigenetic characteristics, metabolic profiles, and respiratory and gut microbiota. By integrating clinical and multi-omics data, the study aims to identify biomarkers associated with immunosenescence, susceptibility to infection, disease severity, and clinical outcomes in older adults. The results are expected to improve understanding of the mechanisms linking aging, immune dysfunction, and infectious diseases, and to support the development of predictive models and preventive strategies for infection management and healthy aging in elderly populations.

Conditions

Immunosenescence

Outcome Measures

Primary Outcomes (1)

• Proportion of peripheral immune cell subset

  Proportion of peripheral blood immune cell subsets in the infection group versus the healthy control group.

  Baseline to 5 years

Secondary Outcomes (3)

• DNA methylation level

  Baseline to 5 years

• Metabolite abundance (metabolomic profiling)

  Baseline to 5 years

• Respiratory and gut microbiota diversity measured by microbiome sequencing

  Baseline to 5 years

Study Arms (2)

Infected Older Adults

Elderly participants aged 60 years or older who meet the study criteria for infectious diseases at enrollment or during the study follow-up period.

Healthy Older Controls

Adults aged 60 years or older who are living independently or receiving routine health examinations and have no evidence of active infection at enrollment or during the study follow-up period.

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:

• No clinical symptoms suggestive of infection, including fever, cough, dyspnea, fatigue, or myalgia.
• No abnormal physical signs, including lymphadenopathy, hepatomegaly, splenomegaly, or skin rash.
• Normal laboratory test results, including complete blood count (CBC), C-reactive protein (CRP), and liver and renal function tests.
• Healthy adults without underlying chronic diseases, no history of infectious diseases within the previous 6 months, and generally normal cognitive function.
• Male or female.
• Able to understand the study procedures and voluntarily provide written informed consent.

You may not qualify if:

• Refusal to participate in the 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, tumor, or other conditions).
• Positive culture results are determined by the clinician to be due to colonization or contamination rather than infection.
• Refusal to participate in the study.
• Patients in critical or severe conditions who are unable to cooperate with sample collection.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Central Study Contacts

Jingwen Ai, MD

CONTACT

86+13764990804; jingwenai1990@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: June 29, 2026
• Study Start: November 29, 2024
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): October 30, 2029
• Last Updated: August 4, 2026

Record last verified: 2026-06

Locations

CN (1)