Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
1 other identifier
observational
300
1 country
1
Brief Summary
This study is aimed to understand the clinical characteristics, etiology and resistance phenotype of major pathogens of SCAP in China through multicenter and prospective investigation. Thus to provide epidemiological basis for improving the SCAP diagnosis and treatment protocol suitable for China.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2018
CompletedFirst Posted
Study publicly available on registry
November 2, 2018
CompletedStudy Start
First participant enrolled
November 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedNovember 2, 2018
November 1, 2018
1.9 years
August 24, 2018
November 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Microbiological profile of lower respiratory tract specimens
Record the microbiological profile of lower respiratory tract specimens, including sputum, nasopharyngeal swabs, tracheobronchial aspirates and BAL fluid.
Day 0 of the study
Microbiological profile of urine specimens
Record the microbiological profile of urine specimens, including all the bacteria explored,especially legionella or streptoccus pneumonia.
Day 0 of the study
Microbiological profile of serum specimens
Record the microbiological profile of serum specimens , including all the bacteria explored, especially legionella, mycoplasma, chlamydia.
Day 0,14 days or 21 days of the study
Secondary Outcomes (7)
General conditions of the participants
Day 0 of the study
Inflammatory Parameters
Day 0, 3 days of the study, and until the end of the study(approximately 1 year).
Arterial Blood Gas analysis of the participants
Day 0 of the study
Chest Image of the participants
Day 0 of the study
Pneumonia Severity Index of the participants
Day 0 of the study
- +2 more secondary outcomes
Study Arms (1)
SCAP groups
all the SCAP patients who meet the inclusion criteria
Eligibility Criteria
SCAP patients who meet the inclusion criteria in China
You may qualify if:
- Age \>18 yeas;
- Diagnosis of CAP according to the diagnosis and treatment of community-acquired pneumonia in adults: 2016 clinical practice guidelines by the Chinese Thoracic Society, Chinese Medical Association.
You may not qualify if:
- Bronchiectasis;
- Active tuberculosis;
- Aspiration pneumonia or obstructive pneumonia;
- Hospitalized in 2 weeks;
- Hospitalized or ventilated ≥5 days;
- Severe immunosuppression patients;
- Irregular follow-up and lost follow-up;
- Withdraw from the study for any reason.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ruijin Hospitallead
Study Sites (1)
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jieming QU, h.D.,M.D.
Ruijin Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Chief Respiratory Physician
Study Record Dates
First Submitted
August 24, 2018
First Posted
November 2, 2018
Study Start
November 10, 2018
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
November 2, 2018
Record last verified: 2018-11