Clinical trial NCT03728816: Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
Official title: Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Community-acquired Pneumonia
Keywords: Community Acquired Pneumonia
Epidemiology
Multicenter study
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: SCAP patients who meet the inclusion criteria in China

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.

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.

Primary outcomes:
measure: Microbiological profile of lower respiratory tract specimens
timeFrame: Day 0 of the study
measure: Microbiological profile of urine specimens
timeFrame: Day 0 of the study
measure: Microbiological profile of serum specimens
timeFrame: Day 0,14 days or 21 days of the study
Secondary outcomes:
measure: General conditions of the participants
timeFrame: Day 0 of the study
measure: Inflammatory Parameters
timeFrame: Day 0, 3 days of the study, and until the end of the study(approximately 1 year).
measure: Arterial Blood Gas analysis of the participants
timeFrame: Day 0 of the study
measure: Chest Image of the participants
timeFrame: Day 0 of the study
measure: Pneumonia Severity Index of the participants
timeFrame: Day 0 of the study
measure: CURB-65 Score of the participants
timeFrame: Day 0 of the study
measure: Prognosis of the SCAP participants
timeFrame: up to 3 days of the study and until the end of the study(approximately 1 year).
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jieming QU, h.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References: