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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mNGS group | Experimental |
| |
| PCR group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mNGS | Diagnostic Test | Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| time for targetted antibiotic treatment | time interval from enrollment to targetted antibiotic treatment initiation | 28 days |
| 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: ①heart rate <100bpm; ② SBP> 90mmHg; ③Body Temperature <38℃; ④ SaO2 > 90% at room temperature; |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongyu Wang, Dr | Contact | 17717366509 | wubywang961208@gmail.com | |
| Jingwen Ai, Dr | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Wenhong Zhang, Prof | Department of Infectious disease, Huashan Hospital, Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Hospital of Jingan District | Not yet recruiting | Shanghai | Shanghai Municipality | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35858876 | Derived | 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. |
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| ID | Term |
|---|---|
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Multiplex PCR | Diagnostic Test | Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment. |
|
| 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 |
| Department of Infectious Disease, Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| Central Hospital of Minhang District | Not yet recruiting | Shanghai | Shanghai Municipality | 201103 | China |
|