Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Acute Respiratory Infection Clinical Trial

— ESAR  

Official title:

Early Identification and Severity Prediction of Acute Respiratory Infectious Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04955756
• Other study ID #: ESAR
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2022
• Source: Huashan Hospital
• Contact: Hongyu Wang, Dr
• Phone: 17717366509
• Email: wubywang961208[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Patients aged between 18 and 80 years old

2. No limits in gender

3. Patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks;

4. 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:

1. Highly suspected or diagnosed pulmonary non-infectious disease (Tumor, Immune disease, etc.) without evidence for infection;

2. Pathogen has been identified without evidence for co-infection;

3. Insufficiency of respiratory and blood samples;

4. Patients who are unable to collaborate due to physical or mental disorders;

5. Patients who have been engaged to other clinical trials;

6. Any conditions make it unsafe for the subject to participate;

Related Conditions & MeSH terms

• Acute Respiratory Infection
• Communicable Diseases
• Infections
• Next Generation Sequencing
• Pneumonia
• Respiratory Tract Infections
• Severe Pneumonia

Intervention

Diagnostic Test:
• mNGS
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
• Multiplex PCR
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.

Locations

Country	Name	City	State
China	Central Hospital of Jingan District	Shanghai	Shanghai
China	Central Hospital of Minhang District	Shanghai	Shanghai
China	Department of Infectious Disease, Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time for targetted antibiotic treatment	time interval from enrollment to targetted antibiotic treatment initiation	28 days
Secondary	Incidence for clinical key events	Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.	28 days
Secondary	Incidence for clinical remission	Incidence for clinical remission, which achieve the following conditions for over 24 hours: ? heart rate <100bpm; ? SBP> 90mmHg; ?Body Temperature <38?; ? SaO2 > 90% at room temperature;	28 days
Secondary	Length of hospitalization;	time interval between admission to hispital and discharge from the hospital when a participant is recovered	28 days
Secondary	Length of ICU admission	time interval from admission to ICU and discharge from ICU	28 days
Secondary	Length from admission to clinical events	time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.	28 days
Secondary	Sampling to Diagnosis Interval	time interval from Sampling to Diagnosis	28 days