Respiratory InfectionsNCT03093220
Molecular Typing of Community-acquired Pneumonia Based on Multiple-omic Data Analysis
An observational study of Respiratory Infections and Genetic Disorder, run by Peking University People's Hospital at 1 site in China.
Trial summary
Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity, mortality and health care burden globally. Typing methods for discriminating different clinical conditions of the same disease are essential to a better management of CAP. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infections, Genetic Disorder, Community-Acquired Infections
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Mar 2017to Dec 2018
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: all adult patients (aged > 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP
Who may be able to join
- adult (aged > 16 years)
- diagnosed as community-acquired pneumonia
Who cannot join
- being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy
- history of long-term nursing home stays
- history of recently hospitalized (<90 days)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Yali Zheng, Dr, 15011451515 ext. 86, drylzheng@gmail.com
About this study
Official title: Molecular Typing of Adult Community-acquired Pneumonia in China
Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity, mortality and health care burden globally. Typing methods for discriminating different clinical conditions of the same disease are essential to a better management of CAP. Traditional typing systems based separately on clinical manifestations (such as PSI and CURB-65), pathogens(bacterial types, virulence, drug resistance, etc) or host immune state (immunocompetent, immunocompromised or immunodeficiency). Thus, they are barely able to represent the real disease status nor to precisely predict the mortality.
As the development of multi-omic technologies, the relatedness of different phenotypes at a molecular level have revolutionized our ability to differentiate among patients. Our study is aimed at establishing a novel molecular typing method of CAP. Multi-omic (including genomics, transcriptomes, and metabolisms) data obtained from enrolled CAP patients and isolated pathogens would be integrated analyzed and interpreted. Tthe investigators believe that an appropriate molecular typing method would lead to revolutionary changes in current arrangements of CAP.
- Conditions
- Respiratory Infections, Genetic Disorder, Community-Acquired Infections, Host-Pathogen Interactions
- Medical subject headings
- Respiratory Tract Infections, Genetic Diseases, Inborn, Community-Acquired Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| community-acquired pneumonia | all adult patients (aged > 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP will be enrolled |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day mortality
all-cause death in 30 days after the onset of CAP
Measured: 30 days after the onset of CAP
Secondary outcomes (1)
complications
nonfatal complications including critical organic or systematic dysfunction
Measured: 30 days after the onset of CAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study startMar 2017 (estimated)
- Primary completion31 Mar 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- CapitalBio Group Corporation, Chinese Academy of Sciences, West China Hospital, Second Hospital of Jilin University, Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Zhancheng Gao, Professor, Study chair, Department of Respiratory Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093220
- Sponsor's protocol ID
- 2016YFC0903800
- Status last verified
- Mar 2017
- First submitted
- 15 Mar 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen L, Xue J, Zhao L, He Y, Fu S, Ma X, Yu W, Tang Y, Wang Y, Gao Z. Lysophosphatidylcholine acyltransferase level predicts the severity and prognosis of patients with community-acquired pneumonia: a prospective multicenter study. Front Immunol. 2024 Jan 8;14:1295353. doi: 10.3389/fimmu.2023.1295353. eCollection 2023.
PubMed 38259459Yin L, Zhang Y, Zheng Y, Luo Q, Zhao L, Ni W, Xu Y, Gao Z. Early Detection of Aspergillus Species in Lower Respiratory Tract is Associated with Higher Mortality in Viral Community-Acquired Pneumonia: A Multicenter Prospective Cohort Study in China. Lung. 2023 Aug;201(4):387-396. doi: 10.1007/s00408-023-00638-2. Epub 2023 Jul 22.
PubMed 37480410Xie Y, Yu Y, Zhao L, Ning P, Luo Q, Zhang Y, Yin L, Zheng Y, Gao Z. Specific Cytokine Profiles Predict the Severity of Influenza A Pneumonia: A Prospectively Multicenter Pilot Study. Biomed Res Int. 2021 Oct 13;2021:9533044. doi: 10.1155/2021/9533044. eCollection 2021.
PubMed 34692846Chen L, Zhao L, Shang Y, Xu Y, Gao Z. Admission lysophosphatidylethanolamine acyltransferase level predicts the severity and prognosis of community-acquired pneumonia. Infection. 2021 Oct;49(5):877-888. doi: 10.1007/s15010-021-01585-x. Epub 2021 Mar 10.
PubMed 33694084Zheng Y, Ning P, Luo Q, He Y, Yu X, Liu X, Chen Y, Wang X, Kang Y, Gao Z. Inflammatory responses relate to distinct bronchoalveolar lavage lipidome in community-acquired pneumonia patients: a pilot study. Respir Res. 2019 May 2;20(1):82. doi: 10.1186/s12931-019-1028-8.
PubMed 31046764Luo Q, He X, Ning P, Zheng Y, Yang D, Xu Y, Shang Y, Gao Z. Admission Pentraxin-3 Level Predicts Severity of Community-Acquired Pneumonia Independently of Etiology. Proteomics Clin Appl. 2019 Jul;13(4):e1800117. doi: 10.1002/prca.201800117. Epub 2019 Feb 12.
PubMed 30557448Ning P, Zheng Y, Luo Q, Liu X, Kang Y, Zhang Y, Zhang R, Xu Y, Yang D, Xi W, Wang K, Chen Y, An S, Gao Z. Metabolic profiles in community-acquired pneumonia: developing assessment tools for disease severity. Crit Care. 2018 May 14;22(1):130. doi: 10.1186/s13054-018-2049-2.
PubMed 29759075Luo Q, Ning P, Zheng Y, Shang Y, Zhou B, Gao Z. Serum suPAR and syndecan-4 levels predict severity of community-acquired pneumonia: a prospective, multi-centre study. Crit Care. 2018 Jan 24;22(1):15. doi: 10.1186/s13054-018-1943-y.
PubMed 29368632
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Typing of Adult Community-acquired Pneumonia in China
- ClinicalTrials.gov ID
- NCT03093220
- Acronym / sponsor ID
- 2016YFC0903800
- Conditions
- Respiratory Infections, Genetic Disorder, Community-Acquired Infections, Host-Pathogen Interactions
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- CapitalBio Group Corporation, Chinese Academy of Sciences, West China Hospital, Second Hospital of Jilin University, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- Mar 2017 (estimated)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 28 Mar 2017 (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.
Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity, mortality and health care burden globally. Typing methods for discriminating different clinical conditions of the same disease are essential to a better management of CAP. Traditional typing systems based separately on clinical manifestations (such as PSI and CURB-65), pathogens(bacterial types, virulence, drug resistance, etc) or host immune state (immunocompetent, immunocompromised or immunodeficiency). Thus, they are barely able to represent the real disease status nor to precisely predict the mortality.
As the development of multi-omic technologies, the relatedness of different phenotypes at a molecular level have revolutionized our ability to differentiate among patients. Our study is aimed at establishing a novel molecular typing method of CAP. Multi-omic (including genomics, transcriptomes, and metabolisms) data obtained from enrolled CAP patients and isolated pathogens would be integrated analyzed and interpreted. Tthe investigators believe that an appropriate molecular typing method would lead to revolutionary changes in current arrangements of CAP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| community-acquired pneumonia | – | –all adult patients (aged > 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP will be enrolled |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all adult patients (aged > 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP
Key inclusion criteria (2 listed)
- adult (aged > 16 years)
- diagnosed as community-acquired pneumonia
Key exclusion criteria (3 listed)
- being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy
- history of long-term nursing home stays
- history of recently hospitalized (<90 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
30 day mortality
Time frame: 30 days after the onset of CAP
all-cause death in 30 days after the onset of CAP
1 secondary outcome
complications
Time frame: 30 days after the onset of CAP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Derived from this study: PubMed 38259459Chen L, Xue J, Zhao L, He Y, Fu S, Ma X, Yu W, Tang Y, Wang Y, Gao Z. Lysophosphatidylcholine acyltransferase level predicts the severity and prognosis of patients with community-acquired pneumonia: a prospective multicenter study. Front Immunol. 2024 Jan 8;14:1295353. doi: 10.3389/fimmu.2023.1295353. eCollection 2023.
- Derived from this study: PubMed 37480410Yin L, Zhang Y, Zheng Y, Luo Q, Zhao L, Ni W, Xu Y, Gao Z. Early Detection of Aspergillus Species in Lower Respiratory Tract is Associated with Higher Mortality in Viral Community-Acquired Pneumonia: A Multicenter Prospective Cohort Study in China. Lung. 2023 Aug;201(4):387-396. doi: 10.1007/s00408-023-00638-2. Epub 2023 Jul 22.
- Derived from this study: PubMed 34692846Xie Y, Yu Y, Zhao L, Ning P, Luo Q, Zhang Y, Yin L, Zheng Y, Gao Z. Specific Cytokine Profiles Predict the Severity of Influenza A Pneumonia: A Prospectively Multicenter Pilot Study. Biomed Res Int. 2021 Oct 13;2021:9533044. doi: 10.1155/2021/9533044. eCollection 2021.
- Derived from this study: PubMed 33694084Chen L, Zhao L, Shang Y, Xu Y, Gao Z. Admission lysophosphatidylethanolamine acyltransferase level predicts the severity and prognosis of community-acquired pneumonia. Infection. 2021 Oct;49(5):877-888. doi: 10.1007/s15010-021-01585-x. Epub 2021 Mar 10.
- Derived from this study: PubMed 31046764Zheng Y, Ning P, Luo Q, He Y, Yu X, Liu X, Chen Y, Wang X, Kang Y, Gao Z. Inflammatory responses relate to distinct bronchoalveolar lavage lipidome in community-acquired pneumonia patients: a pilot study. Respir Res. 2019 May 2;20(1):82. doi: 10.1186/s12931-019-1028-8.
- Derived from this study: PubMed 30557448Luo Q, He X, Ning P, Zheng Y, Yang D, Xu Y, Shang Y, Gao Z. Admission Pentraxin-3 Level Predicts Severity of Community-Acquired Pneumonia Independently of Etiology. Proteomics Clin Appl. 2019 Jul;13(4):e1800117. doi: 10.1002/prca.201800117. Epub 2019 Feb 12.
- Derived from this study: PubMed 29759075Ning P, Zheng Y, Luo Q, Liu X, Kang Y, Zhang Y, Zhang R, Xu Y, Yang D, Xi W, Wang K, Chen Y, An S, Gao Z. Metabolic profiles in community-acquired pneumonia: developing assessment tools for disease severity. Crit Care. 2018 May 14;22(1):130. doi: 10.1186/s13054-018-2049-2.
- Derived from this study: PubMed 29368632Luo Q, Ning P, Zheng Y, Shang Y, Zhou B, Gao Z. Serum suPAR and syndecan-4 levels predict severity of community-acquired pneumonia: a prospective, multi-centre study. Crit Care. 2018 Jan 24;22(1):15. doi: 10.1186/s13054-018-1943-y.
- Individual participant dataSharing planned: No
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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.
Zhancheng Gao, Professor study chair
Department of Respiratory Critical Care Medicine
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 Respiratory Infections and Genetic Disorder, run by Peking University People's Hospital 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 28 Mar 2017. 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 Yali Zheng, Dr (15011451515 ext. 86, drylzheng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day mortality (time frame: 30 days after the onset of CAP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093220, which also lists 8 linked publications.
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 28 Mar 2017.