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A Study of the Mechanisms of Infection Susceptibility Across the Life Course and the Development of an Intelligent Prevention and Control System

12 november 2026 bijgewerkt door: Jingwen Ai, Huashan Hospital

This multicenter, observational registry study aims to characterize host immune, genetic, and microbiome features associated with susceptibility to infection and the risk of severe infection in adults. Approximately 2,195 adults aged 18 years or older undergoing routine health examinations or health screening will be enrolled and followed prospectively for five years. Available clinical information and previously stored biological samples collected since 2019 will also be retrospectively integrated. Demographic characteristics, medical history, medication use, vaccination history, laboratory findings, infection events, treatments, hospitalizations, intensive care admissions, and clinical outcomes will be recorded. Blood, urine, stool, sputum, and nasopharyngeal or oropharyngeal samples will be collected when available to evaluate host immune responses, genetic characteristics, biomarkers, and microbial composition and function. By integrating longitudinal clinical data with biological measurements, the study seeks to identify potential biomarkers and improve infection-risk prediction beyond conventional clinical factors, thereby supporting risk stratification and the development of personalized infection-prevention strategies.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Infectieziekten

Studietype

Observationeel

Inschrijving (Geschat)

2195

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Naam: Jingwen Dr Ai
Telefoonnummer: 86+13764990804
E-mail: jingwenai1990@126.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Adults aged 18 years and older

Beschrijving

Inclusion Criteria:

Aged 18 years or older and undergoing an adult health examination or health screening at a participating center.
No severe organ dysfunction that substantially affects daily living, such as decompensated heart, liver, or kidney failure.
Able to communicate and cooperate with study procedures.
Willing to participate and provides informed consent in accordance with ethics committee-approved requirements.

Exclusion Criteria:

Declines to participate.
Essential clinical information required for the study is unavailable and cannot be obtained after verification.
Considered unsuitable for participation by the investigator; the specific reason will be documented.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Observatiemodellen: COHORT
Tijdsperspectieven: PROSPECTIVE

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Number of the Composite Endpoint of Death or Severe Infection Tijdsspanne: From baseline to Year 5	Number of participants experiencing at least one component of the composite endpoint: all-cause death, infection-related death, or severe infection. Severe infection will be evaluated based on clinically documented outcomes, including infection-related hospitalization, intensive care unit admission, mechanical ventilation, or other life-threatening infection events.	From baseline to Year 5

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Incidence of Overall Infection Tijdsspanne: From baseline to Year 5	Number and proportion of participants who experience at least one clinically documented infection, including respiratory tract infection, bloodstream infection, urinary tract infection, or another confirmed infectious disease.	From baseline to Year 5
Incidence of Respiratory Tract Infection Tijdsspanne: From baseline to Year 5	Number and proportion of participants who experience at least one respiratory tract infection, including upper respiratory tract infection, bronchitis, pneumonia, or another respiratory infection confirmed by clinical diagnosis or pathogen testing.	From baseline to Year 5
Incidence of Bloodstream Infection Tijdsspanne: From baseline to Year 5	Number and proportion of participants who experience at least one clinically documented bloodstream infection, including bacteremia, fungemia, or another bloodstream infection supported by blood culture or other pathogen testing in the presence of clinical signs of infection.	From baseline to Year 5
Incidence of Urinary Tract Infection Tijdsspanne: From baseline to Year 5	Number and proportion of participants who experience at least one urinary tract infection, including cystitis, pyelonephritis, or another urinary tract infection supported by clinical diagnosis, urine pathogen testing, or documented anti-infective treatment.	From baseline to Year 5
Correlation Between Gut Microbiome Alpha Diversity and Infection Episode Rate Tijdsspanne: From baseline to Year 5	Spearman's correlation coefficient (ρ) between baseline gut microbiome alpha diversity (Shannon index) measured from stool samples and infection episode rate (episodes/person-year) obtained from clinical records during follow-up.	From baseline to Year 5
Proportion of peripheral immune cell subset with Infection Susceptibility and Severity Tijdsspanne: From baseline to Year 5	Proportion of peripheral blood immune cell subsets with Infection Susceptibility and Severity	From baseline to Year 5

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Huashan Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

31 december 2032

Studie voltooiing (Geschat)

31 december 2032

Studieregistratiedata

Eerst ingediend

29 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

12 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)