Clinical trial NCT03093220: Molecular Typing of Community-acquired Pneumonia Based on Multiple-omic Data Analysis
Official title: Molecular Typing of Adult Community-acquired Pneumonia in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Infections
Genetic Disorder
Community-Acquired Infections
Host-Pathogen Interactions
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: CapitalBio Group Corporation
name: Chinese Academy of Sciences
name: West China Hospital
name: Second Hospital of Jilin University
name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2017-03-28
Enrollment: 500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adult patients (aged \> 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 days after the onset of CAP
Secondary outcomes:
measure: complications
timeFrame: 30 days after the onset of CAP
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Department of Respiratory Critical Care Medicine
name: Zhancheng Gao, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.