Pathogenic Microorganisms in Adult Severe Pneumonia Patients

A Multicenter Clinical Study on the Detection of Pathogenic Microorganisms in Adult Severe Pneumonia Patients in Liaoning Province

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pathogenic Microorganism of Serious Pneumonia
• Intervention / Treatment: Other: pathogenic microorganism

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital Of China Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Severe pneumonia patients, aged 18 years and above, gender unlimited.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shengjing Hospital
• Collaborators: Huludao central hospital; Chaoyang Central Hospital; Yingkou Central Hospital; Benxi Cental Hospital; Dandong First Hospital; Fushun Mining Bureau General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: June 13, 2020
• First Submitted That Met QC Criteria: June 13, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: PMASP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No