- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03728816
Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
November 1, 2018 updated by: Jieming QU, Ruijin Hospital
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
During the study period, all patients who are diagnosed with SCAP and meet the inclusion criteria in the participating unit should be enrolled in the study . At the end of the trial, each participating unit should complete at least 20 qualified cases, and all participating units should have a total of more than 300 qualified cases.
- Learn about the etiology of SCAP in China.
- Grasp the resistance phenotype and molecular epidemiology of major pathogens of SCAP in China.
- Know the important clinical characteristics of SCAP in China, including age, basic diseases, length of hospital stay, length of stay in ICU, duration of mechanical ventilation, clinical manifestations, imaging findings, complications, mortality, etc.
- Analyze and clarify the clinical risk factors of affecting SCAP mortality.
- Understand the current situation of antibiotic treatment of SCAP in China.
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jieming QU, Ph.D., M.D.
- Phone Number: 0086-021-64370045
- Email: jmqu0906@163.com
Study Contact Backup
- Name: Jing ZHANG, h.D.,M.D.
- Phone Number: 0086-13472782754
- Email: jingatlas@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin hospital Shanghai Jiao Tong University School of Medicine
-
Contact:
- Jieming QU, Ph.D., M.D.
- Phone Number: 0086-021-64370045
- Email: jmqu0906@163.com
-
Principal Investigator:
- Jieming QU, Ph.D., M.D.
-
Principal Investigator:
- Jing ZHANG, Ph.D., M.D.
-
-
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
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
SCAP patients who meet the inclusion criteria in China
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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
Cohorts and Interventions
Group / Cohort |
---|
SCAP groups
all the SCAP patients who meet the inclusion criteria
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiological profile of lower respiratory tract specimens
Time Frame: Day 0 of the study
|
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
Time Frame: Day 0 of the study
|
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
Time Frame: Day 0,14 days or 21 days of the study
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General conditions of the participants
Time Frame: Day 0 of the study
|
Record the general conditions of the participants when included in the study ,such as demographic , clinical symptoms and signs of the participants, legionella contact history , enrollment date, ICU admitted condition, comorbidities, prior antibiotic treatment and so on.
|
Day 0 of the study
|
Inflammatory Parameters
Time Frame: Day 0, 3 days of the study, and until the end of the study(approximately 1 year).
|
Record the levels of WBC, CRP, PCT of the participants.
|
Day 0, 3 days of the study, and until the end of the study(approximately 1 year).
|
Arterial Blood Gas analysis of the participants
Time Frame: Day 0 of the study
|
Record the arterial Blood Gas analysis(pH,PO2,PCO2 etc.) when included in the study.
|
Day 0 of the study
|
Chest Image of the participants
Time Frame: Day 0 of the study
|
Record the chest radiograph of the participants when included in the study.
|
Day 0 of the study
|
Pneumonia Severity Index of the participants
Time Frame: Day 0 of the study
|
Record the pneumonia severity index of the participants according to the PSI scoring system,which has been used to decide whether patients with pneumonia can be treated as outpatients or as (hospitalized) inpatients.
|
Day 0 of the study
|
CURB-65 Score of the participants
Time Frame: Day 0 of the study
|
Assessment of consciousness, urea, respiratory rate, BP, and age 65 years score of the participants(Confusion-1,BUN>7mmol/l-1,Respiratory rate≥30-1,SBP<90mmHg,DBP≤60mmHg-1,Age≥65-1).The risk of death at 30 days increases as the score increases:0-0.6%,1-2.7%,2-6.8%,3-14.0%,4-27.8%,5-27.8%.
|
Day 0 of the study
|
Prognosis of the SCAP participants
Time Frame: up to 3 days of the study and until the end of the study(approximately 1 year).
|
Record the prognosis(cure,improvement,invalid,recrudesce,death) of the participants through the study completion.
|
up to 3 days of the study and until the end of the study(approximately 1 year).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jieming QU, h.D.,M.D., Ruijin Hospital
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)
November 10, 2018
Primary Completion (ANTICIPATED)
September 30, 2020
Study Completion (ANTICIPATED)
September 30, 2020
Study Registration Dates
First Submitted
August 24, 2018
First Submitted That Met QC Criteria
November 1, 2018
First Posted (ACTUAL)
November 2, 2018
Study Record Updates
Last Update Posted (ACTUAL)
November 2, 2018
Last Update Submitted That Met QC Criteria
November 1, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RJ2017NO186-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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