A Study of the Mechanisms of Infection Susceptibility Across the Life Course and the Development of an Intelligent Prevention and Control System
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienkontakt
- Name: Jingwen Dr Ai
- Telefonnummer: 86+13764990804
- E-Mail: jingwenai1990@126.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Adults aged 18 years and older
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: COHORT
- Zeitperspektiven: PROSPECTIVE
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of the Composite Endpoint of Death or Severe Infection
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Incidence of Overall Infection
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: From baseline to Year 5
|
Proportion of peripheral blood immune cell subsets with Infection Susceptibility and Severity |
From baseline to Year 5
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- KY2026-
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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