Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Study 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.

Official Title
-----------------
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Conditions
-----------------
Acute Respiratory Infection, Severe Pneumonia, Next Generation Sequencing, Multiplex PCR

Intervention / Treatment
-----------------
* Diagnostic Test: mNGS
* Diagnostic Test: Multiplex PCR


Participation Criteria
=================
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: fever; 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;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mNGS group<br> | Diagnostic Test: mNGS<br>* Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.<br>|
| Experimental: PCR group<br> | Diagnostic Test: Multiplex PCR<br>* Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time for targetted antibiotic treatment | time interval from enrollment to targetted antibiotic treatment initiation | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence for clinical key events | Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT. | 28 days | 
| Incidence for clinical remission | Incidence for clinical remission, which achieve the following conditions for over 24 hours: ① heart rate <100bpm; ② SBP> 90mmHg; ③Body Temperature <38℃; ④ SaO2 > 90% at room temperature; | 28 days | 
| Length of hospitalization; | time interval between admission to hispital and discharge from the hospital when a participant is recovered | 28 days | 
| Length of ICU admission | time interval from admission to ICU and discharge from ICU | 28 days | 
| Length from admission to clinical events | time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT. | 28 days | 
| Sampling to Diagnosis Interval | time interval from Sampling to Diagnosis | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mNGS, Multiplex PCR, Acute Respiratory Infectious Disease, Severe Pneumonia