Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:00 AM
Study NCT ID:
NCT06011902
Status:
UNKNOWN
Last Update Posted:
2023-08-25
First Post:
2023-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000085142', 'term': 'Severe Fever with Thrombocytopenia Syndrome'}], 'ancestors': [{'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D002044', 'term': 'Bunyaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2023-08-21', 'lastUpdatePostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presense of clinical symptoms of patients at 3 months and 6 months after discharge', 'timeFrame': '3 months,6 months', 'description': 'The number and severity of clinical symptoms of patients.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with different outcome of disease', 'timeFrame': '6 months', 'description': 'Number of participants who experience these events:\n\n1. discharge with improvement\n2. death\n3. automatic discharge'}]}, 'conditionsModule': {'conditions': ['Severe Fever With Thrombocytopenia Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, retrospective clinical study to analyze the clinical features, laboratory indicators, imaging changes, treatment options and long-term prognosis in patients with sever fever with thrombocytopenia syndrome. All hospitalized patients with sever fever with thrombocytopenia diagnosed between 2016 and 2022 were included from the electronic medical record system of 8 centers, and demographics, hospitalization information, clinical information, laboratory or imaging examinations, treatment options, and outcomes were collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome from 8 centers in Hubei Province, China.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age and gender are not limited;\n* Hospitalized patients diagnosed with severe fever with thrombocytopenia syndrome have at least one of the following laboratory test results: serum severe fever with thrombocytopenia syndrome bunyavirus (SFTSV)-specific IgM antibody positive or IgG antibody level increased more than 4 times; or positive for SFTSV RNA; or positive for SFTSV nucleic acid detected by real-time fluorescent quantitative RT-PCR; or SFTSV isolated from case specimens.\n\nExclusion Criteria:\n\n* Patients who were found to be positive for other tick-borne pathogens by PCR analysis of blood samples in the acute phase;\n* It is difficult to conduct outpatient follow-up due to mental disorders, dementia, combined diseases such as osteoarthropathy, stroke, pulmonary embolism, etc. that lead to inability to move freely;\n* No outpatient follow-up visit after discharge, and repeated confirmation by phone call still unable to get in touch;\n* Due to living in other places, nursing homes, welfare homes, unable to participate in outpatient follow-up after making an appointment by phone;\n* Currently participating in clinical trials of other drugs or medical devices;\n* The researchers think it is not suitable for inclusion.'}, 'identificationModule': {'nctId': 'NCT06011902', 'briefTitle': 'A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'A 6-month Follow-up Study of Patients With Severe Fever With Thrombocytopenia Syndrome', 'orgStudyIdInfo': {'id': 'RESORT'}}, 'contactsLocationsModule': {'locations': [{'city': 'Guangshui', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'qian Liu', 'role': 'CONTACT', 'email': 'liuqian060685@163.com'}], 'facility': 'NO.1 Peoples Hospital of Guangshui', 'geoPoint': {'lat': 31.6199, 'lon': 113.9978}}, {'city': 'Huanggang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yaping Li', 'role': 'CONTACT', 'email': '1061319323@qq.com'}], 'facility': 'Huanggang Central Hospital', 'geoPoint': {'lat': 30.45143, 'lon': 114.87035}}, {'city': 'Huanggang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'wei Wang', 'role': 'CONTACT', 'email': '196436547@qq.com'}], 'facility': "People's Hospital Of Luotian County", 'geoPoint': {'lat': 30.45143, 'lon': 114.87035}}, {'city': 'Macheng', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'yi Zhou', 'role': 'CONTACT', 'email': '2513478349@qq.com'}], 'facility': "People's Hospital of Macheng city Affiliated Hospital of Hubei Univerciy of science and technology", 'geoPoint': {'lat': 31.18013, 'lon': 115.02213}}, {'city': 'Suizhou', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'tiantong Zhou', 'role': 'CONTACT', 'email': '2063151328@qq.com'}], 'facility': 'Suizhou Central Hospital', 'geoPoint': {'lat': 31.71111, 'lon': 113.36306}}, {'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qin Ning, professor', 'role': 'CONTACT', 'email': 'qning@vip.sina.com'}], 'facility': 'Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Xianning', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'jun Zhu', 'role': 'CONTACT', 'email': '1356266581@qq.com'}], 'facility': 'Xianning Central Hospital', 'geoPoint': {'lat': 29.84347, 'lon': 114.32201}}, {'city': 'Yichang', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'quan Ming', 'role': 'CONTACT', 'email': '737695825@qq.com'}], 'facility': 'Yichang Third Peoples Hospital', 'geoPoint': {'lat': 30.71444, 'lon': 111.28472}}], 'centralContacts': [{'name': 'Qin Ning, Professor', 'role': 'CONTACT', 'email': 'qning@vip.sina.com', 'phone': '+8613971521450'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongji Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Chair of Department of Infectious Diseases', 'investigatorFullName': 'Qin Ning', 'investigatorAffiliation': 'Tongji Hospital'}}}}