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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jingwen Dr Ai
- Numéro de téléphone: 86+13764990804
- E-mail: jingwenai1990@126.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Adults aged 18 years and older
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: COHORT
- Perspectives temporelles: PROSPECTIVE
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of the Composite Endpoint of Death or Severe Infection
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Overall Infection
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: From baseline to Year 5
|
Proportion of peripheral blood immune cell subsets with Infection Susceptibility and Severity |
From baseline to Year 5
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KY2026-
Informations sur les médicaments et les dispositifs, documents d'étude
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