Community-acquired PneumoniaNCT03728816
Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
An observational study of Community-acquired Pneumonia, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Community-acquired Pneumonia
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2018to 30 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SCAP patients who meet the inclusion criteria in China
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jieming QU, Ph.D., M.D., 0086-021-64370045, jmqu0906@163.com
Jieming QU, Ph.D., M.D.
About this study
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.
Read the 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.
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community Acquired Pneumonia, Epidemiology, Multicenter study
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCAP groups | all the SCAP patients who meet the inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 0,14 days or 21 days of the study
Secondary outcomes (7)
General conditions of the participants
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.
Measured: Day 0 of the study
Inflammatory Parameters
Record the levels of WBC, CRP, PCT of the participants.
Measured: Day 0, 3 days of the study, and until the end of the study(approximately 1 year).
Arterial Blood Gas analysis of the participants
Record the arterial Blood Gas analysis(pH,PO2,PCO2 etc.) when included in the study.
Measured: Day 0 of the study
Chest Image of the participants
Record the chest radiograph of the participants when included in the study.
Measured: Day 0 of the study
Pneumonia Severity Index of the participants
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.
Measured: Day 0 of the study
CURB-65 Score of the participants
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%.
Measured: Day 0 of the study
Prognosis of the SCAP participants
Record the prognosis(cure,improvement,invalid,recrudesce,death) of the participants through the study completion.
Measured: up to 3 days of the study and until the end of the study(approximately 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start10 Nov 2018 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jieming QU, Ruijin Hospital
- Investigators
- Jieming QU, h.D.,M.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03728816
- Sponsor's protocol ID
- RJ2017NO186-1
- Status last verified
- Nov 2018
- First submitted
- 24 Aug 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
- ClinicalTrials.gov ID
- NCT03728816
- Acronym / sponsor ID
- RJ2017NO186-1
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community Acquired Pneumonia, Epidemiology, Multicenter study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 10 Nov 2018 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCAP groups | – | –all the SCAP patients who meet the inclusion criteria |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SCAP patients who meet the inclusion criteria in China
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- Bronchiectasis;
- Active tuberculosis;
- Aspiration pneumonia or obstructive pneumonia;
- Hospitalized in 2 weeks;
- Hospitalized or ventilated ≥5 days;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
7 secondary outcomes
General conditions of the participants
Time frame: 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).
Arterial Blood Gas analysis of the participants
Time frame: Day 0 of the study
Chest Image of the participants
Time frame: Day 0 of the study
Pneumonia Severity Index of the participants
Time frame: Day 0 of the study
CURB-65 Score of the participants
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jieming QU, h.D.,M.D. principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jieming QU, Ph.D., M.D. (0086-021-64370045, jmqu0906@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological profile of lower respiratory tract specimens (time frame: Day 0 of the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.