Infectious DiseasesNCT07644962
Research Project on the Interaction Between Immune Function and Infectious Diseases in Older Adults and the Development of Prevention and Control Strategies
An observational study of Infectious Diseases and Immunosenescence, run by Huashan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infectious Diseases, Immunosenescence, Aging
- How many people
- 23,000 participants
- Where
- No sites listed yet
- Study dates
- 9 Jun 2026to 30 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 60 years and older
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 years
Secondary outcomes (3)
High-Frequency Infection Status (≥6 Infections per Year)
Defined as an average of six or more infectious episodes per year during follow-up.
Measured: Baseline to 3 Years
Pathogen-Specific Infection Events
Infectious disease events caused by specific pathogens, used to evaluate pathogen distribution and temporal trends.
Measured: Baseline to 3 Years
Changes in Immune Function Biomarkers
Assessment of longitudinal changes in immune cell subsets and immune function status.
Measured: Baseline to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start9 Jun 2026 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644962
- Sponsor's protocol ID
- 20260306-001
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Project on the Interaction Between Immune Function and Infectious Diseases in Older Adults and the Development of Prevention and Control Strategies
- ClinicalTrials.gov ID
- NCT07644962
- Acronym / sponsor ID
- 20260306-001
- Conditions
- Infectious Diseases, Immunosenescence, Aging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 23,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 9 Jun 2026 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 60 years and older
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- General Cohort Exclusion Criteria
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence of infectious disease outcomes in older adults
Time frame: 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.
3 secondary outcomes
High-Frequency Infection Status (≥6 Infections per Year)
Time frame: Baseline to 3 Years
Pathogen-Specific Infection Events
Time frame: Baseline to 3 Years
Changes in Immune Function Biomarkers
Time frame: Baseline to 3 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Diseases and Immunosenescence, run by Huashan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Ai (17317958269, jingwenai1990@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of infectious disease outcomes in older adults (time frame: Baseline to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.