NCT06288074

Brief Summary

Severe community-acquired pneumonia still has a high incidence and mortality, but the molecular mechanism and prognostic biomarkers of severe community-acquired pneumonia caused by different pathogens are still unclear, and the best treatment strategy has not been determined. Based on this, this project intends to take patients with severe community-acquired pneumonia caused by different pathogens as the research object, explore the molecular mechanism of severe community-acquired pneumonia from multiple angles, integrate relevant research data to evaluate the rationality of initial empirical medication, and lay the foundation for precise treatment of severe pneumonia. The research results will help to develop a new rapid and accurate target for clinical diagnosis and efficacy evaluation of severe pneumonia, and build a precise treatment system for severe pneumonia.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 1, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

January 3, 2024

Last Update Submit

February 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hospital mortality

    during hospitalization (up to day 14)

Secondary Outcomes (4)

  • Cause of death

    during hospitalization (up to day 14)

  • Length of stay

    during hospitalization (up to day 14)

  • Length of ICU stay

    during hospitalization (up to day 14)

  • Expense during hospitalization

    during hospitalization (up to day 14)

Study Arms (3)

Severe community-acquired pneumonia

Diagnostic Test: Multi-omics tests

Non-Severe community-acquired pneumonia

Diagnostic Test: Multi-omics tests

Healthy control

Diagnostic Test: Multi-omics tests

Interventions

Multi-omics testsDIAGNOSTIC_TEST

Biological sample collection for Multi-omics tests

Healthy controlNon-Severe community-acquired pneumoniaSevere community-acquired pneumonia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A prospective cohort including 100 patients with severe and 100 patients with non-severe community-acquired pneumonia and 100 healthy people was selected.

You may qualify if:

  • Age\> 18 years old
  • Clinical diagnosis of community-acquired pneumonia

You may not qualify if:

  • Pregnancy, perinatal and lactating women
  • Combined immunosuppressive diseases: such as HIV, solid organ transplantation, solid organ/hematologic malignant tumor chemotherapy, rheumatic diseases or glomerular diseases need to take hormone/immunosuppressant therapy
  • Combined blood system diseases: such as leukemia reactions, aplastic anemia, neutropenia or deficiency of granulocytes, previous bone marrow/stem cell transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Institute of Respiratory Medicine

Beijing, Beijing Municipality, 100027, China

RECRUITING

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 3, 2024

First Posted

March 1, 2024

Study Start

March 10, 2024

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 1, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

IPD is to be uploaded to the public platform and made public to all researchers.

Locations