Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Huashan Hospital3 sites in 1 country440 target enrollmentApril 4, 2021

ConditionsAcute Respiratory Infection Severe Pneumonia Next Generation Sequencing Multiplex PCR

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Acute Respiratory Infection
Sponsor: Huashan Hospital
Enrollment: 440
Locations: 3
Primary Endpoint: time for targetted antibiotic treatment
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Early identification and Severity prediction of Acute Respiratory infectious disease has become a top priority for clinicians at department of infectious and respiratory diseases after COVID-19 broke out. This is a multicenter, prospective, and randomized study, which aims to figure out the best way of early identification and severity prediction of acute respiratory infectious diseases. Patients with suspected acute respiratory infectious diseases will be enrolled into this study and received two different diagnostic pathways.

Registry

clinicaltrials.gov

Start Date

April 4, 2021

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Huashan Hospital

Responsible Party

Principal Investigator

Wen-hong Zhang

chairman of the infectious disease department

Huashan Hospital

Eligibility Criteria

Inclusion Criteria

•Patients aged between 18 and 80 years old
•No limits in gender
•Patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks;
•Patients who meet at least one of the following 4 requirements:
•Sign of pulmonary consolidation or wet wales
•WBC\>10×10\^9/L or \<4×10\^9/L;
•patchy, infiltrating shadows or interstitial changes, with or without pleural effusion on chest radiological examination.

Exclusion Criteria

•Highly suspected or diagnosed pulmonary non-infectious disease (Tumor, Immune disease, etc.) without evidence for infection;
•Pathogen has been identified without evidence for co-infection;
•Insufficiency of respiratory and blood samples;
•Patients who are unable to collaborate due to physical or mental disorders;
•Patients who have been engaged to other clinical trials;
•Any conditions make it unsafe for the subject to participate;