Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
NCT ID: NCT04955756
Last Updated: 2022-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
440 participants
INTERVENTIONAL
2021-04-04
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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mNGS group
mNGS
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
PCR group
Multiplex PCR
Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
80 Years
ALL
No
Sponsors
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Huashan Hospital
OTHER
Responsible Party
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Wen-hong Zhang
chairman of the infectious disease department
Principal Investigators
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Wenhong Zhang, Prof
Role: STUDY_CHAIR
Department of Infectious disease, Huashan Hospital, Fudan University
Locations
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Central Hospital of Jingan District
Shanghai, Shanghai Municipality, China
Department of Infectious Disease, Huashan Hospital
Shanghai, Shanghai Municipality, China
Central Hospital of Minhang District
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Jingwen Ai, Dr
Role: CONTACT
Facility Contacts
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Wenhong Zhang, Prof
Role: primary
Xiang Li, Prof
Role: primary
References
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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.
Other Identifiers
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ESAR
Identifier Type: -
Identifier Source: org_study_id
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