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Molecular Typing of Community-acquired Pneumonia Based on Multiple-omic Data Analysis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03093220
Recruitment Status : Unknown
Verified March 2017 by Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : March 28, 2017
Last Update Posted : March 28, 2017
Sponsor:
Collaborators:
CapitalBio Group Corporation
Chinese Academy of Sciences
West China Hospital
Second Hospital of Jilin University
Shanghai Pulmonary Hospital, Shanghai, China
Information provided by (Responsible Party):
Peking University People's Hospital

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.


Condition or disease
Respiratory Infections Genetic Disorder Community-Acquired Infections Host-Pathogen Interactions

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular Typing of Adult Community-acquired Pneumonia in China
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : March 31, 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Group/Cohort
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



Primary Outcome Measures :
  1. 30 day mortality [ Time Frame: 30 days after the onset of CAP ]
    all-cause death in 30 days after the onset of CAP


Secondary Outcome Measures :
  1. complications [ Time Frame: 30 days after the onset of CAP ]
    nonfatal complications including critical organic or systematic dysfunction


Biospecimen Retention:   Samples With DNA
  1. Lower respiratory tract specimens including sputum, endotracheal aspiration and bronchoalveolar lavage fluid.
  2. Peripheral whole blood samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093220


Contacts
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Contact: Yali Zheng, Dr 15011451515 ext 86 drylzheng@gmail.com

Locations
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China, Beijing
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100044
Contact: Yali Zheng, Dr    15011451515 ext 86    drylzheng@gmail.com   
Sponsors and Collaborators
Peking University People's Hospital
CapitalBio Group Corporation
Chinese Academy of Sciences
West China Hospital
Second Hospital of Jilin University
Shanghai Pulmonary Hospital, Shanghai, China
Investigators
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Study Chair: Zhancheng Gao, Professor Department of Respiratory Critical Care Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03093220    
Other Study ID Numbers: 2016YFC0903800
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Community-Acquired Infections
Pneumonia
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases