Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-01-01 @ 8:44 PM
Study NCT ID:
NCT01770067
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-26', 'studyFirstSubmitDate': '2013-01-15', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lack of CIED Infection', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiac Resynchronization Therapy Devices'], 'conditions': ['Infection']}, 'referencesModule': {'references': [{'pmid': '36631206', 'type': 'DERIVED', 'citation': 'Topaz M, Chorin E, Schwartz AL, Hochstadt A, Shotan A, Ashkenazi I, Kazatsker M, Carmel NN, Topaz G, Oron Y, Margolis G, Nof E, Beinart R, Glikson M, Mazo A, Milman A, Dekel M, Banai S, Rosso R, Viskin S. Regional Antibiotic Delivery for Implanted Cardiovascular Electronic Device Infections. J Am Coll Cardiol. 2023 Jan 17;81(2):119-133. doi: 10.1016/j.jacc.2022.10.022.'}]}, 'descriptionModule': {'briefSummary': 'Following previous positive experience with regulated CITA-RNPT of infected CIEDs, we suggest increasing the number of recruited patients and that CITA-RNPT can be administered prophylactically to patients prior to replacement of previously treated CIEDs, immuno-compromised patients, and others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High-risk patients for CIED infections\n* CIED infections\n\nExclusion Criteria:\n\n* Systematic infection'}, 'identificationModule': {'nctId': 'NCT01770067', 'briefTitle': 'Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Prospective Evaluation of the Efficacy and Safety of Continuous In-situ Ultra High-dose Antibiotics (CITA) and Minimally Invasive Surgery (MIS) Utilizing Regulated Negative Pressure-assisted Wound Therapy (RNPT) in the Salvage of Infected Cardiovascular Implantable Electronic Devices (CIED) by Localized High-dose Antibiotics', 'orgStudyIdInfo': {'id': '0093-12-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infected CIED and Infection-Prone Patients Prior to CIED Implantation', 'description': 'Administration of high-dose antibiotics (CITA)', 'interventionNames': ['Drug: CITA-RNPT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infected CIED extraction', 'description': 'Extraction of infected CIED', 'interventionNames': ['Procedure: Extraction of infected CIED']}], 'interventions': [{'name': 'CITA-RNPT', 'type': 'DRUG', 'armGroupLabels': ['Infected CIED and Infection-Prone Patients Prior to CIED Implantation']}, {'name': 'Extraction of infected CIED', 'type': 'PROCEDURE', 'armGroupLabels': ['Infected CIED extraction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'facility': 'Tel Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Moris Topaz, MD, PhD', 'role': 'CONTACT', 'email': 'topazmd@netvision.net.il', 'phone': '972505251122'}], 'overallOfficials': [{'name': 'Moris Topaz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}