Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT07158502
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antimicrobial Strategy for Device Implantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of CIEDs related infections', 'timeFrame': 'From enrollment to the end of 12 months', 'description': 'To determine the incidence of infections related to cardiovascular implantable electronic devices (CIEDs) at 12 months in patients who received TauroPace™ during the implantation procedure.'}], 'secondaryOutcomes': [{'measure': 'Safety Profile of TauroPace™', 'timeFrame': 'From enrollment to 1 week after implantation', 'description': 'To detect and describe any adverse events potentially related to the use of TauroPace'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CIED-related Infections']}, 'descriptionModule': {'briefSummary': 'Infections associated with cardiovascular implantable electronic devices (CIEDs) represent one of the major postoperative complications in interventional cardiology. These infections-including lead-related endocarditis, subcutaneous pocket infections, and sepsis-are characterized by high rates of morbidity, mortality, and healthcare costs. According to current epidemiological data, the incidence of CIED-related infections is estimated to be around 0.5-2% within the first 12 months and may rise to 5% over long-term follow-up. These infections are associated with a mortality rate of up to 34% and often require device explantation and prolonged antibiotic therapy.\n\nTauroPace™ is an antimicrobial solution based on taurolidine, a broad-spectrum, non-antibiotic agent that acts by disrupting bacterial biofilms and preventing microbial colonization. Taurolidine has a favorable safety profile, does not induce antibiotic resistance, and is already approved in Europe as a CE-marked medical device (Directive 93/42/EEC). The application of TauroPace™ to the surface of CIEDs prior to implantation may significantly reduce the incidence of infections compared to the current standard, which consists of irrigating the device pocket with sterile saline solution.\n\nThe aim of this study is to rigorously and systematically evaluate the effectiveness of TauroPace™ compared to standard clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing implantation or generator replacement of cardiovascular implantable electronic devices (CIEDs). Participants will be consecutively enrolled during routine clinical activity over the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinical indication for CIED implantation or generator replacement\n* Signed informed consent to participate in the study\n\nExclusion Criteria:\n\n* Known allergy to taurolidine or any of the excipients\n* Severe immunodeficiency status (e.g., patients undergoing chemotherapy, with AIDS, or immunosuppressed following organ transplantation)\n* Life expectancy \\< 12 months due to severe comorbidities (e.g., metastatic cancer, end-stage organ failure)\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT07158502', 'briefTitle': 'Antimicrobial Strategy for Device Implantation', 'organization': {'class': 'OTHER', 'fullName': 'University of Calabria'}, 'officialTitle': 'Prevention of Infections Associated With Implantable Cardiac Devices', 'orgStudyIdInfo': {'id': '195/2025'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TauroPace Cohort', 'interventionNames': ['Drug: TauroPace Cohort']}], 'interventions': [{'name': 'TauroPace Cohort', 'type': 'DRUG', 'description': 'After sterile opening of the vial, the entire content of TauroPace™ will be poured into single-use sterile trays. Following skin incision, the surgical site will be irrigated with 5 mL of TauroPace™ solution.\n\nThe leads, device generator, and fixation sutures will then be thoroughly wiped using sterile gauze soaked in the solution. Once the leads are connected to the generator, the entire system will be treated again with TauroPace™ before being inserted into the pocket.\n\nAt the end of the procedure, the final surgical site will be irrigated once more with an additional 5 mL of TauroPace™ using a sterile syringe. A full 100 mL vial of the solution will be used for each patient, ensuring continuous antimicrobial coverage throughout the procedure.\n\nExcess solution will be gently removed prior to surgical wound closure.', 'armGroupLabels': ['TauroPace Cohort']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Antonio Curcio', 'role': 'CONTACT', 'email': 'antonio.curcio.cardio@unical.it', 'phone': '+390984681889'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calabria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Antonio Curcio', 'investigatorAffiliation': 'University of Calabria'}}}}