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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04433403
Other study ID # PMASP
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date June 30, 2024

Study information

Verified date September 2021
Source Shengjing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to evaluate pathogenic microorganisms in adult severe pneumonia patients in different cities of Liaoning Province


Description:

The pathogenic microorganisms of adult patients with severe pneumonia is detected in this study. Clinical treatment does not involve , so it meets the ethical requirements. The clinical data, laboratory test results and imaging data of adult severe pneumonia patients in different hospitals in different cities are recorded. The pathogenic microorganism is detected by second-generation sequencing of lower respiratory tract sputum or alveolar lavage fluid samples, and the data were sorted out to draw the pathogenic microorganism spectrum of adult severe pneumonia in Liaoning area. It will be used to guide clinical empirical treatment.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 300
Est. completion date June 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Meet the standard of severe pneumonia: Main standards: Requiring mechanical ventilation or septic shock requiring vasoconstrictor therapy. Secondary standards:(only if 3 items are met) Disturbance of consciousness; respiratory rate = 30 times/min; PaO2/FiO2 = 250, or PaO2 < 60mmHg; azotemia (BUN = 7.12mmol / L); hypotension requires strong fluid resuscitation; infiltration of multiple lobes; leucopenia (WBC < 4 × 109 / L); thrombocytopenia (< 10 × 109 / L); hypothermia (T < 36 ?). Exclusion Criteria: - refuse to sign informed consent; inaccurate results due to unqualified sputum or BALF samples

Study Design


Related Conditions & MeSH terms

  • Pathogenic Microorganism of Serious Pneumonia
  • Pneumonia

Intervention

Other:
pathogenic microorganism
Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing

Locations

Country Name City State
China Shengjing hospital of China Medical University Shenyang Liaoning

Sponsors (7)

Lead Sponsor Collaborator
Shengjing Hospital Benxi Cental Hospital, Chaoyang Central Hospital, Dandong First Hospital, Fushun Mining Bureau General Hospital, Huludao central hospital, Yingkou Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pathogenic microorganism spectrum of adult severe pneumonia in Liaoning Province Detection of pathogenic microorganisms in severe pneumonia by second generation sequencing 2020.7-2023.12