Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China

Community-acquired Pneumonia Clinical Trial

Official title:

Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03728816
• Other study ID #: RJ2017NO186-1
• Status: Recruiting
• Start date: November 10, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2018
• Source: Ruijin Hospital
• Contact: Jieming QU, Ph.D., M.D.
• Phone: 0086-021-64370045
• Email: jmqu0906[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

1. Learn about the etiology of SCAP in China.

2. Grasp the resistance phenotype and molecular epidemiology of major pathogens of SCAP in China.

3. 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.

4. Analyze and clarify the clinical risk factors of affecting SCAP mortality.

5. Understand the current situation of antibiotic treatment of SCAP in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Community-acquired Pneumonia
• Pneumonia

Locations

Country	Name	City	State
China	Ruijin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	Day 0 of the study
Secondary	Inflammatory Parameters	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).
Secondary	Arterial Blood Gas analysis of the participants	Record the arterial Blood Gas analysis(pH,PO2,PCO2 etc.) when included in the study.	Day 0 of the study
Secondary	Chest Image of the participants	Record the chest radiograph of the participants when included in the study.	Day 0 of the study
Secondary	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.	Day 0 of the study
Secondary	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%.	Day 0 of the study
Secondary	Prognosis of the SCAP participants	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).