Ignite Creation Date:
2025-12-24 @ 12:00 PM
Ignite Modification Date:
2026-01-01 @ 1:52 AM
Study NCT ID:
NCT06221761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002056', 'term': 'Burns'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants do not know which group they will be assigned to.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly divided into two groups, one using antibiotics and the other not using antibiotics'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 240}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-14', 'studyFirstSubmitDate': '2023-12-26', 'studyFirstSubmitQcDate': '2024-01-14', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Negative rate of bacterial culture', 'timeFrame': 'hour 72', 'description': 'Number of cases with negative wound culture bacteria/total number of cases'}], 'secondaryOutcomes': [{'measure': '28 day mortality rate', 'timeFrame': '28 day after burn', 'description': '28 day mortality rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['burn', 'infection', 'antibiotic'], 'conditions': ['Burn Infection']}, 'referencesModule': {'references': [{'pmid': '27542292', 'type': 'RESULT', 'citation': 'ISBI Practice Guidelines Committee; Steering Subcommittee; Advisory Subcommittee. ISBI Practice Guidelines for Burn Care. Burns. 2016 Aug;42(5):953-1021. doi: 10.1016/j.burns.2016.05.013.'}, {'pmid': '20156911', 'type': 'RESULT', 'citation': 'Avni T, Levcovich A, Ad-El DD, Leibovici L, Paul M. Prophylactic antibiotics for burns patients: systematic review and meta-analysis. BMJ. 2010 Feb 15;340:c241. doi: 10.1136/bmj.c241.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare in acute burn patients.\n\nThe main question it aims to answer are:\n\n• what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group.\n\nResearchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed and dated informed consent form\n* Promise to comply with research procedures and cooperate with the implementation of full process research\n* Age 18 and above\n* Emergency hospitalization of patients in the burn department, within 24 hours after injury\n* No immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission\n* If a woman is in the reproductive period, she should not be pregnant\n\nExclusion Criteria:\n\n* Unable to obtain informed consent from subjects, family members, or authorized agents\n* At the time of admission, antibiotics were being administered\n* During pregnancy\n* Presence of infectious diseases before admission\n* Existence of immunodeficiency diseases or use of immunosuppressive drugs\n* The subjects are currently undergoing other clinical studies'}, 'identificationModule': {'nctId': 'NCT06221761', 'briefTitle': 'A Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'A Prospective Randomized Controlled Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients', 'orgStudyIdInfo': {'id': '20231226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Non antibiotic group', 'description': 'Not using antibiotics within 72 hours after burns', 'interventionNames': ['Drug: not using antibiotic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'antibiotic group', 'description': 'Using antibiotics within 72 hours after burns', 'interventionNames': ['Drug: using antibiotic']}], 'interventions': [{'name': 'not using antibiotic', 'type': 'DRUG', 'description': 'no antibiotic application', 'armGroupLabels': ['Non antibiotic group']}, {'name': 'using antibiotic', 'type': 'DRUG', 'description': 'antibiotic application', 'armGroupLabels': ['antibiotic group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dou Yi', 'role': 'CONTACT', 'email': 'douyi815@hotmail.com', 'phone': '862164370045', 'phoneExt': '661033'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}