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

March 22, 2017 updated by: Peking University People's Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100044
    - Recruiting
    - Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30 day mortality Time Frame: 30 days after the onset of CAP	all-cause death in 30 days after the onset of CAP	30 days after the onset of CAP

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications Time Frame: 30 days after the onset of CAP	nonfatal complications including critical organic or systematic dysfunction	30 days after the onset of CAP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

West China Hospital

Chinese Academy of Sciences

Shanghai Pulmonary Hospital, Shanghai, China

Second Hospital of Jilin University

CapitalBio Group Corporation

Investigators

Study Chair: Zhancheng Gao, Professor, Department of Respiratory Critical Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2017

Primary Completion (Anticipated)

March 31, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 22, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)