Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2025-12-25 @ 9:24 PM
Study NCT ID:
NCT04955756
Status:
UNKNOWN
Last Update Posted:
2022-05-12
First Post:
2021-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 440}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2022-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time for targetted antibiotic treatment', 'timeFrame': '28 days', 'description': 'time interval from enrollment to targetted antibiotic treatment initiation'}], 'secondaryOutcomes': [{'measure': 'Incidence for clinical key events', 'timeFrame': '28 days', 'description': 'Incidence for clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.'}, {'measure': 'Incidence for clinical remission', 'timeFrame': '28 days', '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;'}, {'measure': 'Length of hospitalization;', 'timeFrame': '28 days', 'description': 'time interval between admission to hispital and discharge from the hospital when a participant is recovered'}, {'measure': 'Length of ICU admission', 'timeFrame': '28 days', 'description': 'time interval from admission to ICU and discharge from ICU'}, {'measure': 'Length from admission to clinical events', 'timeFrame': '28 days', 'description': 'time interval from admission to hospital to clinical events including tracheal intubation, tracheotomy, ECMO, and CRRT.'}, {'measure': 'Sampling to Diagnosis Interval', 'timeFrame': '28 days', 'description': 'time interval from Sampling to Diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mNGS', 'Multiplex PCR', 'Acute Respiratory Infectious Disease', 'Severe Pneumonia'], 'conditions': ['Acute Respiratory Infection', 'Severe Pneumonia', 'Next Generation Sequencing', 'Multiplex PCR']}, 'referencesModule': {'references': [{'pmid': '35858876', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged between 18 and 80 years old\n2. No limits in gender\n3. Patients who are newly present with cough, sputum, or exacerbated with pyogenic sputum, with or without chest pain within 2 weeks;\n4. Patients who meet at least one of the following 4 requirements:\n\n 1. fever;\n 2. Sign of pulmonary consolidation or wet wales\n 3. WBC\\>10×10\\^9/L or \\<4×10\\^9/L;\n 4. patchy, infiltrating shadows or interstitial changes, with or without pleural effusion on chest radiological examination.\n\nExclusion Criteria:\n\n1. Highly suspected or diagnosed pulmonary non-infectious disease (Tumor, Immune disease, etc.) without evidence for infection;\n2. Pathogen has been identified without evidence for co-infection;\n3. Insufficiency of respiratory and blood samples;\n4. Patients who are unable to collaborate due to physical or mental disorders;\n5. Patients who have been engaged to other clinical trials;\n6. Any conditions make it unsafe for the subject to participate;'}, 'identificationModule': {'nctId': 'NCT04955756', 'acronym': 'ESAR', 'briefTitle': 'Early Identification and Severity Prediction of Acute Respiratory Infectious Disease', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'Early Identification and Severity Prediction of Acute Respiratory Infectious Disease', 'orgStudyIdInfo': {'id': 'ESAR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mNGS group', 'interventionNames': ['Diagnostic Test: mNGS']}, {'type': 'EXPERIMENTAL', 'label': 'PCR group', 'interventionNames': ['Diagnostic Test: Multiplex PCR']}], 'interventions': [{'name': 'mNGS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.', 'armGroupLabels': ['mNGS group']}, {'name': 'Multiplex PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.', 'armGroupLabels': ['PCR group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Wenhong Zhang, Prof', 'role': 'CONTACT', 'phone': '021-61578000'}], 'facility': 'Central Hospital of Jingan District', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongyu Wang', 'role': 'CONTACT', 'email': 'rubywang961208@gmail.com', 'phone': '17717366509'}], 'facility': 'Department of Infectious Disease, Huashan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201103', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiang Li, Prof', 'role': 'CONTACT', 'phone': '021-64923400'}], 'facility': 'Central Hospital of Minhang District', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongyu Wang, Dr', 'role': 'CONTACT', 'email': 'wubywang961208@gmail.com', 'phone': '17717366509'}, {'name': 'Jingwen Ai, Dr', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Wenhong Zhang, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Infectious disease, Huashan Hospital, Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chairman of the infectious disease department', 'investigatorFullName': 'Wen-hong Zhang', 'investigatorAffiliation': 'Huashan Hospital'}}}}