Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-01 @ 12:46 PM
Study NCT ID:
NCT07107932
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury
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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-03', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-08-03', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Outcome', 'timeFrame': 'within 90 days', 'description': 'Tetanus protection rate within 90 days post-administration of Siltartoxatug Injection (calculated as 1- tetanus incidence rate)'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome', 'timeFrame': 'within 90 days', 'description': 'Classification of wound characteristics in patients receiving Siltartoxatug Injection'}, {'measure': 'Secondary Outcome', 'timeFrame': 'within 90 days', 'description': 'Incidence of adverse reactions and serious adverse events within 90 days post-administration of Siltartoxatug Injection'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tetanus Prophylaxis'], 'conditions': ['Tetanus']}, 'descriptionModule': {'briefSummary': 'The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving Siltartoxatug for tetanus prophylaxis following injury and providing informed consent for participation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1.Having received or will receive Siltartoxatug for tetanus prophylaxis following injury;\n* 2\\. Provided signed informed consent by themselves or their legal representatives.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT07107932', 'briefTitle': 'A Registry： Siltartoxatug Injection for Tetanus Prophylaxis Following Injury', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zhuhai Trinomab Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Large-Sample Real-World Dynamic Cohort Registry: Observing the Clinical Outcomes of Siltartoxatug Injection for Tetanus Prophylaxis Following Injury', 'orgStudyIdInfo': {'id': 'TNM002-402'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Siltartoxatug Injection (Brand name: Sintetol®)', 'interventionNames': ['Drug: Siltartoxatug Injection (Brand name: Sintetol®)']}], 'interventions': [{'name': 'Siltartoxatug Injection (Brand name: Sintetol®)', 'type': 'DRUG', 'description': 'The injury and wound conditions of the enrolled patients will be documented. A follow-up at 90 days post-administration will determine the clinical outcome of tetanus prophylaxis, specifically whether tetanus occurred. The registry will also employ selective safety data collection to record adverse reactions and serious adverse events following Siltartoxatug adminstration.', 'armGroupLabels': ['Siltartoxatug Injection (Brand name: Sintetol®)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Tianliang Huang, Doctor', 'role': 'CONTACT', 'email': '276578698@qq.com', 'phone': '+86 13531168261'}], 'facility': 'The Second Affiliated Hospital of Shantou University', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '672100', 'city': 'Xiangyun', 'state': 'Yunnan', 'country': 'China', 'facility': "Xiangyun County People's Hospital", 'geoPoint': {'lat': 27.87668, 'lon': 103.96735}}, {'zip': '312030', 'city': 'Shaoxing', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Liyun Wang', 'role': 'CONTACT', 'phone': '+86 0575-85580999'}], 'facility': 'Shaoxing Central Hospital', 'geoPoint': {'lat': 30.00237, 'lon': 120.57864}}, {'zip': '316100', 'city': 'Zhoushan', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Li Hu', 'role': 'CONTACT', 'phone': '+86 0580-3030785'}], 'facility': "Zhoushan Putuo District People's Hospital", 'geoPoint': {'lat': 29.98869, 'lon': 122.20488}}], 'centralContacts': [{'name': 'Xia Qu, Master', 'role': 'CONTACT', 'email': 'sammi.qu@trinomab.com', 'phone': '+86 0756 726399'}, {'name': 'xinyu Liu, Doctor', 'role': 'CONTACT', 'email': 'liuxinyu@trinomab.com', 'phone': '+86 0756 7263999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhuhai Trinomab Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}