Back to resultsEarly Identification and Severity Prediction of Acute Respiratory Infectious Disease (ESAR)
Primary Purpose
Acute Respiratory Infection, Severe Pneumonia, Next Generation Sequencing
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
mNGS
Multiplex PCR
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Respiratory Infection focused on measuring mNGS, Multiplex PCR, Acute Respiratory Infectious Disease, Severe Pneumonia
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;
Sites / Locations
- Central Hospital of Jingan District
- Department of Infectious Disease, Huashan HospitalRecruiting
- Central Hospital of Minhang District
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
mNGS group
PCR group
Arm Description
Outcomes
Primary Outcome Measures
time for targetted antibiotic treatment
time interval from enrollment to targetted antibiotic treatment initiation
Secondary Outcome Measures
Incidence for clinical key events
Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
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;
Length of hospitalization;
time interval between admission to hispital and discharge from the hospital when a participant is recovered
Length of ICU admission
time interval from admission to ICU and discharge from ICU
Length from admission to clinical events
time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Sampling to Diagnosis Interval
time interval from Sampling to Diagnosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04955756
Brief Title
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
Acronym
ESAR
Official Title
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infection, Severe Pneumonia, Next Generation Sequencing, Multiplex PCR
Keywords
mNGS, Multiplex PCR, Acute Respiratory Infectious Disease, Severe Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
440 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mNGS group
Arm Type
Experimental
Arm Title
PCR group
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
mNGS
Intervention Description
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
Intervention Type
Diagnostic Test
Intervention Name(s)
Multiplex PCR
Intervention Description
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
Primary Outcome Measure Information:
Title
time for targetted antibiotic treatment
Description
time interval from enrollment to targetted antibiotic treatment initiation
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Incidence for clinical key events
Description
Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Time Frame
28 days
Title
Incidence for clinical remission
Description
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;
Time Frame
28 days
Title
Length of hospitalization;
Description
time interval between admission to hispital and discharge from the hospital when a participant is recovered
Time Frame
28 days
Title
Length of ICU admission
Description
time interval from admission to ICU and discharge from ICU
Time Frame
28 days
Title
Length from admission to clinical events
Description
time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Time Frame
28 days
Title
Sampling to Diagnosis Interval
Description
time interval from Sampling to Diagnosis
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongyu Wang, Dr
Phone
17717366509
Email
wubywang961208@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jingwen Ai, Dr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenhong Zhang, Prof
Organizational Affiliation
Department of Infectious disease, Huashan Hospital, Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Central Hospital of Jingan District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenhong Zhang, Prof
Phone
021-61578000
Facility Name
Department of Infectious Disease, Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyu Wang
Phone
17717366509
Email
rubywang961208@gmail.com
Facility Name
Central Hospital of Minhang District
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201103
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang Li, Prof
Phone
021-64923400
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35858876
Citation
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.
Results Reference
derived
Learn more about this trial
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
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