NCT03093220

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.1 years

First QC Date

March 15, 2017

Last Update Submit

March 22, 2017

Conditions

Respiratory InfectionsGenetic DisorderCommunity-Acquired InfectionsHost-Pathogen Interactions

Outcome Measures

Primary Outcomes (1)

  • 30 day mortality

    all-cause death in 30 days after the onset of CAP

    30 days after the onset of CAP

Secondary Outcomes (1)

  • complications

    30 days after the onset of CAP

Study Arms (1)

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

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all adult patients (aged \> 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP

You may qualify if:

  • adult (aged \> 16 years)
  • diagnosed as community-acquired pneumonia

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (8)

  • 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.

    PMID: 38259459DERIVED

  • Yin 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.

    PMID: 37480410DERIVED

  • Xie 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.

    PMID: 34692846DERIVED

  • Chen 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.

    PMID: 33694084DERIVED

  • Zheng 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.

    PMID: 31046764DERIVED

  • Luo 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.

    PMID: 30557448DERIVED

  • Ning 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.

    PMID: 29759075DERIVED

  • Luo 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.

    PMID: 29368632DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

1. Lower respiratory tract specimens including sputum, endotracheal aspiration and bronchoalveolar lavage fluid. 2. Peripheral whole blood samples

MeSH Terms

Conditions

Respiratory Tract InfectionsGenetic Diseases, InbornCommunity-Acquired Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Zhancheng Gao, Professor

    Department of Respiratory Critical Care Medicine

    STUDY CHAIR

Central Study Contacts

Yali Zheng, Dr

CONTACT

15011451515drylzheng@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2017

First Posted

March 28, 2017

Study Start

March 1, 2017

Primary Completion

March 31, 2018

Study Completion

December 1, 2018

Last Updated

March 28, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)