Rapid Diagnosis of Severe Respiratory Tract Infectious Diseases and Screening of Biomarkers for Stratified Diagnosis

NCT06533514 | Not Yet Recruiting

• 1 other identifier: Pneumonia and Biomarkers
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to clarify the biomarkers for rapid diagnosis and stratified diagnosis of severe respiratory tract infectious diseases through clinical experiments.

Conditions

Severe Pneumonia; Biomarkers

Outcome Measures

Primary Outcomes (1)

• The relationship between the patient's specific biomarker levels and clinical outcomes.

  Treatment failure rate, Mortality rates, SOFA rating scale

  1 mounth

Study Arms (3)

mild

According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe.

moderate

According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe.

severe

According to the APACHE II score, SOFA score and PSI score, the enrolled patients were divided into three groups: mild, moderate and severe.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Meets the diagnostic criteria for severe pneumonia；

You may qualify if:

• Meets the diagnostic criteria for severe pneumonia；
• Age≥18 years old and \< 80 years old；
• Willing to sign informed consent for the course of the study；

You may not qualify if:

• Patients with intracranial hypertension, acute coronary syndrome, pleural fistula, pneumothorax, or subcutaneous emphysema;
• Pregnant and lactating patients;
• Severely hemodynamically unstable (an increase in vasopressors by more than 30% in the first 6 hours, or norepinephrine \>0.5mg/kg/min);
• Those who do not consent to participate in this study；

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage specimens

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

fei xie, doctor

CONTACT

13911385976; xiefei0522@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy chief physician

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 1, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share