Severe Community-acquired PneumoniaNCT06288074
Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration
An observational study of Severe Community-acquired Pneumonia, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Severe Community-acquired Pneumonia
- What is being tested?
- Multi-omics tests
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age> 18 years old
- Clinical diagnosis of community-acquired pneumonia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Institute of Respiratory Medicine
Beijing, Beijing Municipality, 100027
Zhaohui Tong, Dr, +86 010 8523 1000, 13910930309@163.com
About this study
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.
- Conditions
- Severe Community-acquired Pneumonia
- Being tested
- Multi-omics tests
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-omics testsDiagnostic test
Biological sample collection for Multi-omics tests
| Study group | Role | What they receive |
|---|---|---|
| Severe community-acquired pneumonia | Not described Receives: Diagnostic Test: Multi-omics tests | |
| Non-Severe community-acquired pneumonia | Not described Receives: Diagnostic Test: Multi-omics tests | |
| Healthy control | Not described Receives: Diagnostic Test: Multi-omics tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital mortality
Measured: during hospitalization (up to day 14)
Secondary outcomes (4)
Cause of death
Measured: during hospitalization (up to day 14)
Length of stay
Measured: during hospitalization (up to day 14)
Length of ICU stay
Measured: during hospitalization (up to day 14)
Expense during hospitalization
All expenses incurred in hospitalization, including bed fee, examination fee, operation or treatment fee.
Measured: during hospitalization (up to day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start10 Mar 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaohui Tong, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288074
- Sponsor's protocol ID
- SF-2022-1-1061
- Status last verified
- Feb 2024
- First submitted
- 3 Jan 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is to be uploaded to the public platform and made public to all researchers.
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Treatment Strategy Optimization of Severe Pneumonia Based on Multi-omics Data Integration
- ClinicalTrials.gov ID
- NCT06288074
- Acronym / sponsor ID
- SF-2022-1-1061
- Conditions
- Severe Community-acquired Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 10 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age> 18 years old
- Clinical diagnosis of community-acquired pneumonia
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-omics testsBiological sample collection for Multi-omics tests | Diagnostic test | Healthy control, Non-Severe community-acquired pneumonia, Severe community-acquired pneumonia |
Primary outcome
Hospital mortality
Time frame: during hospitalization (up to day 14)
4 secondary outcomes
Cause of death
Time frame: during hospitalization (up to day 14)
Length of stay
Time frame: during hospitalization (up to day 14)
Length of ICU stay
Time frame: during hospitalization (up to day 14)
Expense during hospitalization
Time frame: during hospitalization (up to day 14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: Yes. IPD is to be uploaded to the public platform and made public to all researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Community-acquired Pneumonia, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaohui Tong, Dr (+86 139 1093 0309, 13910930309@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital mortality (time frame: during hospitalization (up to day 14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2024.