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Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China

Multicenter Epidemiologic Study of Severe Community Acquired Pneumonia in China

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03728816
Enrollment
300
Registered
2018-11-02
Start date
2018-11-10
Completion date
2020-09-30
Last updated
2018-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community-acquired Pneumonia

Keywords

Community Acquired Pneumonia, Epidemiology, Multicenter study

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.

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Microbiological profile of lower respiratory tract specimensDay 0 of the studyRecord the microbiological profile of lower respiratory tract specimens, including sputum, nasopharyngeal swabs, tracheobronchial aspirates and BAL fluid.
Microbiological profile of urine specimensDay 0 of the studyRecord the microbiological profile of urine specimens, including all the bacteria explored,especially legionella or streptoccus pneumonia.
Microbiological profile of serum specimensDay 0,14 days or 21 days of the studyRecord the microbiological profile of serum specimens , including all the bacteria explored, especially legionella, mycoplasma, chlamydia.

Secondary

MeasureTime frameDescription
Chest Image of the participantsDay 0 of the studyRecord the chest radiograph of the participants when included in the study.
Pneumonia Severity Index of the participantsDay 0 of the studyRecord 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.
General conditions of the participantsDay 0 of the studyRecord 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.
Prognosis of the SCAP participantsup 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.
CURB-65 Score of the participantsDay 0 of the studyAssessment 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%.
Inflammatory ParametersDay 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 participantsDay 0 of the studyRecord the arterial Blood Gas analysis(pH,PO2,PCO2 etc.) when included in the study.

Countries

China

Contacts

Primary ContactJieming QU, Ph.D., M.D.
jmqu0906@163.com0086-021-64370045
Backup ContactJing ZHANG, h.D.,M.D.
jingatlas@hotmail.com0086-13472782754

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026