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

8. juni 2026 opdateret af: Wen-hong Zhang, Huashan Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Undersøgelsestype

Observationel

Tilmelding (Anslået)

23000

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Adults aged 60 years and older

Beskrivelse

Inclusion Criteria:

- General Cohort Inclusion Criteria

  1. 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.
  2. Male or female.
  3. Able to understand the study and voluntarily provide written informed consent.

Infection Cohort Inclusion Criteria

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

Exclusion Criteria:

  • General Cohort Exclusion Criteria

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

Infection Cohort Exclusion Criteria

  1. Final primary diagnosis is a non-infectious disease (e.g., connective tissue disease, malignancy, or other non-infectious conditions).
  2. Positive culture results determined by the treating clinician to represent colonization or contamination rather than true infection.
  3. Refusal to participate in this study.
  4. Critically ill patients or those unable to cooperate with specimen collection procedures.
  5. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Occurrence of infectious disease outcomes in older adults
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
High-Frequency Infection Status (≥6 Infections per Year)
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline to 3 Years
Assessment of longitudinal changes in immune cell subsets and immune function status.
Baseline to 3 Years

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Metabolomic and Microbiome Profiles
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

9. juni 2026

Primær færdiggørelse (Anslået)

30. december 2029

Studieafslutning (Anslået)

30. december 2029

Datoer for studieregistrering

Først indsendt

8. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 20260306-001

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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