Acute Respiratory InfectionESARNCT04955756
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
A study testing mNGS and Multiplex PCR in people with Acute Respiratory Infection and Severe Pneumonia, run by Huashan Hospital at 3 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Infection, Severe Pneumonia, Next Generation Sequencing
- What is being tested?
- mNGS and Multiplex PCR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- 3 sitesChina
- Study dates
- 4 Apr 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
3 sites in 1 country.
Jingwen Ai, Dr contact
China3 sites, 3 recruiting
- Not yet recruiting
Central Hospital of Jingan District
Shanghai, Shanghai Municipality, 200040
Wenhong Zhang, Prof, 021-61578000
- Recruiting
Department of Infectious Disease, Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Hongyu Wang, 17717366509, rubywang961208@gmail.com
- Not yet recruiting
Central Hospital of Minhang District
Shanghai, Shanghai Municipality, 201103
Xiang Li, Prof, 021-64923400
About this study
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.
- Being tested
- mNGS, Multiplex PCR
- Keywords
- mNGS, Multiplex PCR, Acute Respiratory Infectious Disease, Severe Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mNGSDiagnostic test
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
Multiplex PCRDiagnostic test
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
| Study group | Role | What they receive |
|---|---|---|
| mNGS group | Experimental | Not described Receives: Diagnostic Test: mNGS |
| PCR group | Experimental | Not described Receives: Diagnostic Test: Multiplex PCR |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for targetted antibiotic treatment
time interval from enrollment to targetted antibiotic treatment initiation
Measured: 28 days
Secondary outcomes (6)
Incidence for clinical key events
Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Measured: 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;
Measured: 28 days
Length of hospitalization;
time interval between admission to hispital and discharge from the hospital when a participant is recovered
Measured: 28 days
Length of ICU admission
time interval from admission to ICU and discharge from ICU
Measured: 28 days
Length from admission to clinical events
time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.
Measured: 28 days
Sampling to Diagnosis Interval
time interval from Sampling to Diagnosis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start4 Apr 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
- Investigators
- Wenhong Zhang, Prof, Study chair, Department of Infectious disease, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04955756
- Sponsor's protocol ID
- ESAR
- Acronym
- ESAR
- Status last verified
- May 2022
- First submitted
- 18 Jun 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35858876
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
- ClinicalTrials.gov ID
- NCT04955756
- Acronym / sponsor ID
- ESAR / ESAR
- Keywords
- mNGS, Multiplex PCR, Acute Respiratory Infectious Disease, Severe Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 4 Apr 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mNGS group | Experimental | Diagnostic Test: mNGS |
| PCR group | Experimental | Diagnostic Test: Multiplex PCR |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mNGSParticipants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment. | Diagnostic test | mNGS group |
| Multiplex PCRParticipants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment. | Diagnostic test | PCR group |
Primary outcome
time for targetted antibiotic treatment
Time frame: 28 days
time interval from enrollment to targetted antibiotic treatment initiation
6 secondary outcomes
Incidence for clinical key events
Time frame: 28 days
Incidence for clinical remission
Time frame: 28 days
Length of hospitalization;
Time frame: 28 days
Length of ICU admission
Time frame: 28 days
Length from admission to clinical events
Time frame: 28 days
Sampling to Diagnosis Interval
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 35858876Yuan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jingwen Ai, Dr contact
Wenhong Zhang, Prof study chair
Department of Infectious disease, Huashan Hospital, Fudan University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mNGS and Multiplex PCR in people with Acute Respiratory Infection and Severe Pneumonia, run by Huashan Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongyu Wang, Dr (17717366509, wubywang961208@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time for targetted antibiotic treatment (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04955756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.