Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration

February 24, 2024 updated by: Zhaohui Tong, Capital Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100027
        • Recruiting
        • Beijing Institute of Respiratory Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

Inclusion Criteria:

Age> 18 years old

Clinical diagnosis of community-acquired pneumonia

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy control
Diagnostic test: Multi-omics tests
Biological sample collection for Multi-omics tests
Severe community-acquired pneumonia
Diagnostic test: Multi-omics tests
Biological sample collection for Multi-omics tests
Non-Severe community-acquired pneumonia
Diagnostic test: Multi-omics tests
Biological sample collection for Multi-omics tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital mortality
Time Frame: during hospitalization (up to day 14)
during hospitalization (up to day 14)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cause of death
Time Frame: during hospitalization (up to day 14)
during hospitalization (up to day 14)
Length of stay
Time Frame: during hospitalization (up to day 14)
during hospitalization (up to day 14)
Length of ICU stay
Time Frame: during hospitalization (up to day 14)
during hospitalization (up to day 14)
Expense during hospitalization
Time Frame: during hospitalization (up to day 14)
All expenses incurred in hospitalization, including bed fee, examination fee, operation or treatment fee.
during hospitalization (up to day 14)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 10, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Estimated)

March 1, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 24, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF-2022-1-1061

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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