Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-03-02 @ 4:06 AM
Study NCT ID:
NCT04165928
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2019-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study of Tetanus Patients in Fujian Province of China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2019-11-14', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcomes of the tetanus patients', 'timeFrame': '2008-01-01~2018-10-31', 'description': 'The survival data of tetanus patients.'}], 'secondaryOutcomes': [{'measure': 'The hospitalization time.', 'timeFrame': '2008-01-01~2018-10-31', 'description': 'The total length of hospitalization and the length of stay in the ICU.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neonatal tetanus', 'tetanus immunization program', 'drug-induced', 'tetanus antitoxin', 'critical care medicine', 'artificial airway'], 'conditions': ['Tetanus']}, 'descriptionModule': {'briefSummary': "Background: Tetanus is a life-threatening disease in developing countries, and accompanied by a high mortality rate. China is the world's largest developing country, and Fujian Province is a typical coastal province in China with a relatively developed economy. Therefore, the purpose of this study was to investigate the epidemiology, incidence and management of tetanus in Fujian Province and to understand the current treatment and prognosis of tetanus patients in China.\n\nMethods: This was a retrospective multicenter observational study of patients who presented with a clinical diagnosis of tetanus at 5 general hospitals in Fujian. Data was analyzed using computer software system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus.\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT04165928', 'briefTitle': 'Multicenter Study of Tetanus Patients in Fujian Province of China', 'organization': {'class': 'OTHER', 'fullName': 'Fujian Provincial Hospital'}, 'officialTitle': 'Multicenter Study of Tetanus Patients in Fujian Province of China', 'orgStudyIdInfo': {'id': 'K2018-09-005'}}, 'contactsLocationsModule': {'locations': [{'zip': '350000', 'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Deputy Director of the Physician', 'investigatorFullName': 'Xiuling Shang', 'investigatorAffiliation': 'Fujian Provincial Hospital'}}}}