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Clinical Trials/NCT03728816
NCT03728816
Unknown
Not Applicable

Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China

Ruijin Hospital1 site in 1 country300 target enrollmentNovember 10, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Community-acquired Pneumonia
Sponsor
Ruijin Hospital
Enrollment
300
Locations
1
Primary Endpoint
Microbiological profile of lower respiratory tract specimens
Last Updated
7 years ago

Overview

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.

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. 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.

Registry
clinicaltrials.gov
Start Date
November 10, 2018
End Date
September 30, 2020
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jieming QU

Associate Chief Respiratory Physician

Ruijin Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • 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)
  • CURB-65 Score of the participants(Day 0 of the study)
  • Prognosis of the SCAP participants(up to 3 days of the study and until the end of the study(approximately 1 year).)

Study Sites (1)

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