Early Identification and Severity Prediction of Acute Respiratory Infectious Disease (ESAR)

Fudan University

Status

Enrolling

Conditions

Acute Respiratory Infection

Multiplex PCR

Next Generation Sequencing

Severe Pneumonia

Treatments

Diagnostic Test: Multiplex PCR

Diagnostic Test: mNGS

Study type

Interventional

Funder types

Other

Identifiers

NCT04955756

ESAR

Details and patient eligibility

About

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.

Enrollment

440 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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:
1. fever;
2. Sign of pulmonary consolidation or wet wales
3. WBC>10×10^9/L or <4×10^9/L;
4. 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;