Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
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|ClinicalTrials.gov Identifier: NCT03728816|
Recruitment Status : Unknown
Verified November 2018 by Jieming QU, Ruijin Hospital.
Recruitment status was: Recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
|Condition or disease|
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|
|Estimated Enrollment :||300 participants|
|Official Title:||Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China|
|Estimated Study Start Date :||November 10, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
all the SCAP patients who meet the inclusion criteria
- 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.
- 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.
- 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.
- 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.
- Chest Image of the participants [ Time Frame: Day 0 of the study ]Record the chest radiograph of the participants when included in 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.
- 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%.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728816
|Contact: Jieming QU, Ph.D., M.D.||firstname.lastname@example.org|
|Contact: Jing ZHANG, h.D.,M.D.||email@example.com|
|Ruijin Hospital Shanghai Jiao Tong University School of Medicine||Recruiting|
|Shanghai, Shanghai, China, 200025|
|Contact: Jieming QU, Ph.D., M.D. 0086-021-64370045 firstname.lastname@example.org|
|Principal Investigator: Jieming QU, Ph.D., M.D.|
|Principal Investigator: Jing ZHANG, Ph.D., M.D.|
|Principal Investigator:||Jieming QU, h.D.,M.D.||Ruijin Hospital|