ESAR: Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Sponsor

Huashan Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04955756

Collaborator

(none)

440

Enrollment

Locations

Arms

44.9

Anticipated Duration (Months)

146.7

Patients Per Site

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Infection Severe Pneumonia Next Generation Sequencing Multiplex PCR	Diagnostic Test: mNGS Diagnostic Test: Multiplex PCR	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

440 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Actual Study Start Date :

Apr 4, 2021

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mNGS group	Diagnostic Test: mNGS Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
Experimental: PCR group	Diagnostic Test: Multiplex PCR Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.

Arm

Intervention/Treatment

Experimental: mNGS group

Diagnostic Test: mNGS

Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.

Experimental: PCR group

Diagnostic Test: Multiplex PCR

Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.

Outcome Measures

Primary Outcome Measures

time for targetted antibiotic treatment [28 days]
time interval from enrollment to targetted antibiotic treatment initiation

Secondary Outcome Measures

Incidence for clinical key events [28 days]
Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Incidence for clinical remission [28 days]
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;
Length of hospitalization; [28 days]
time interval between admission to hispital and discharge from the hospital when a participant is recovered
Length of ICU admission [28 days]
time interval from admission to ICU and discharge from ICU
Length from admission to clinical events [28 days]
time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Sampling to Diagnosis Interval [28 days]
time interval from Sampling to Diagnosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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:
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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Hospital of Jingan District	Shanghai	Shanghai	China	200040
2	Department of Infectious Disease, Huashan Hospital	Shanghai	Shanghai	China	200040
3	Central Hospital of Minhang District	Shanghai	Shanghai	China	201103