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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Infection; Severe Pneumonia; Next Generation Sequencing; Multiplex PCR
• Intervention / Treatment: Diagnostic test: mNGS; Diagnostic test: Multiplex PCR

• Study Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongyu Wang, Dr; Phone Number: 17717366509; Email: wubywang961208@gmail.com
• Study Contact Backup: Name: Jingwen Ai, Dr

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Not yet recruiting
      • Central Hospital of Jingan District
      • Contact: Wenhong Zhang, Prof; Phone Number: 021-61578000
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Department of Infectious Disease, Huashan Hospital
      • Contact: Hongyu Wang; Phone Number: 17717366509; Email: rubywang961208@gmail.com
    • Shanghai, Shanghai, China, 201103
      • Not yet recruiting
      • Central Hospital of Minhang District
      • Contact: Xiang Li, Prof; Phone Number: 021-64923400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Huashan Hospital
• Investigators: Study Chair: Wenhong Zhang, Prof, Department of Infectious disease, Huashan Hospital, Fudan University

Publications and helpful links

General Publications

• Yuan G, Wang H, Zhao Y, Mao E, Li M, Wang R, Zhou F, Jin S, Zhang Z, Xu K, Xu J, Liang S, Li X, Jiang L, Zhang L, Song J, Yang T, Guo J, Zhang H, Zhou Y, Wang S, Qiu C, Jiang N, Ai J, Wu J, Zhang W. Early identification and severity prediction of acute respiratory infection (ESAR): a study protocol for a randomized controlled trial. BMC Infect Dis. 2022 Jul 20;22(1):632. doi: 10.1186/s12879-022-07552-7.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2021
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 18, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 11, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Multiplex PCR; Severe Pneumonia; mNGS; Acute Respiratory Infectious Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infections; Communicable Diseases; Pneumonia; Respiratory Tract Infections
• Other Study ID Numbers: ESAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No