An observational study in Infectious Diseases, sponsored by Huashan Hospital. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Huashan Hospital · Observational
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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.
627 studies on the registry are indexed under Communicable Diseases; 129 are open to participants now.
This study's planned enrollment of 2,195 is above the median of 200 across 229 observational studies indexed under Communicable Diseases.
Browse Communicable Diseases studies →Huashan Hospital is the lead sponsor of 248 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults aged 18 years and older
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of the Composite Endpoint of Death or Severe Infection
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.
Time frame: From baseline to Year 5
Incidence of Overall Infection
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.
Time frame: From baseline to Year 5
Incidence of Respiratory Tract Infection
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.
Time frame: From baseline to Year 5
Incidence of Bloodstream Infection
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.
Time frame: From baseline to Year 5
Incidence of Urinary Tract Infection
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.
Time frame: From baseline to Year 5
Correlation Between Gut Microbiome Alpha Diversity and Infection Episode Rate
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.
Time frame: From baseline to Year 5
Proportion of peripheral immune cell subset with Infection Susceptibility and Severity
Proportion of peripheral blood immune cell subsets with Infection Susceptibility and Severity
Time frame: From baseline to Year 5
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Dec 2032, 73 months later.
Of 128 non-industry observational studies under Communicable Diseases, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 77. This study's planned 73 months is above that.
Counting every sponsor, half of 142 studies reached it within 37 months; a quarter within 17 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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