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

Genetic Disorder Clinical Trial

Official title:

Molecular Typing of Adult Community-acquired Pneumonia in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03093220
• Other study ID #: 2016YFC0903800
• Status: Recruiting
• Phase: N/A
• First received: March 15, 2017
• Last updated: March 22, 2017
• Start date: March 2017
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Peking University People's Hospital
• Contact: Yali Zheng, Dr
• Phone: 15011451515
• Email: drylzheng[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Community-Acquired Infections
• Genetic Disorder
• Host-Pathogen Interactions
• Infection
• Pneumonia
• Respiratory Infections
• Respiratory Tract Infections

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Peking University People's Hospital	CapitalBio Group Corporation, Chinese Academy of Sciences, Second Hospital of Jilin University, Shanghai Pulmonary Hospital, Shanghai, China, West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30 day mortality	all-cause death in 30 days after the onset of CAP	30 days after the onset of CAP
Secondary	complications	nonfatal complications including critical organic or systematic dysfunction	30 days after the onset of CAP