Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 5:13 AM
Study NCT ID:
NCT06866535
Status:
RECRUITING
Last Update Posted:
2025-03-10
First Post:
2024-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VIP - Vascular Infection Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001025', 'term': 'Aortitis'}, {'id': 'D007239', 'term': 'Infections'}], 'ancestors': [{'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2032-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-05', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2032-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'Year 1', 'description': 'mortality r'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': 'Day 30, Year 2, Year 5', 'description': 'mortality rate'}, {'measure': 'morbidity', 'timeFrame': 'Year 1', 'description': 'morbidity rate'}, {'measure': 'relapse', 'timeFrame': 'year 1, Year 2, Year 5', 'description': 'relapse rates'}, {'measure': 'reinfection', 'timeFrame': 'year 1, Year 2, Year 5', 'description': 'reinfection rates'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vascular graft and endograft infections', 'infectious aortitis', 'infectious arteritis'], 'conditions': ['Aortitis', 'Vascular Graft Infection', 'Blood Vessel Prosthesis', 'Infections']}, 'descriptionModule': {'briefSummary': 'Constitution of a prospective multicentric observational database to study vascular infections, both native, especially aortitis, and vascular graft and endograft infections. Clinical and paraclinical data on medical, surgical, anesthetic and intensive care management will be collected in order to better characterize these infections', 'detailedDescription': 'Vascular infections are rare but severe, burdened by high morbi-mortality and recurrence rates. However, many questions remain regarding their management which is still not consensual, both surgical and medical management. The term "vascular infections" encompasses vascular graft and endograft infections, as well as infections of native arteries and the aorta. For vascular graft infections, the optimal surgery is to remove the infected graft before vascular reconstruction with a new graft, either synthetic or biologic. However, some patients are too fragile to undergo surgery and might then benefit from an endovascular graft, an abscess drainage or no surgery at all, only medical treatment. For native arterial infections, surgery is often required to remove the infected arterial wall before vascular reconstruction. However, some patients cannot be operated on and might also benefit from an endovascular surgery. In these two vascular infections, the ideal anti-microbial treatment is uncertain, whether it pertains to the duration of therapy, the type of molecules, or their number. All of these medical and surgical factors may impact the prognosis of patients and should be collectively assessed in order to determine the best strategy for enhancing their outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ents with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 years-old;\n* all patients with a vascular infection, either native (aortitis, arteritis) or prosthetic (vascular graft, endograft and/or stent),\n* oral consent\n\nExclusion Criteria:\n\n* patient under legal protection'}, 'identificationModule': {'nctId': 'NCT06866535', 'acronym': 'Cohorte VIP', 'briefTitle': 'VIP - Vascular Infection Project', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'VIP - Vascular Infection Project : Prospective Multicentric Database on Vascular Infections', 'orgStudyIdInfo': {'id': 'CHUBX 2022/01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Native vascular infection'}, {'label': 'Prosthetic vascular infections'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mathilde Puges, MD', 'role': 'CONTACT', 'email': 'mathilde.puges@chu-bordeaux.fr', 'phone': '+335 56 79 55 36'}], 'facility': 'CHU Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}], 'centralContacts': [{'name': 'Mathilde Puges, MD', 'role': 'CONTACT', 'email': 'mathilde.puges@chu-bordeaux.fr', 'phone': '+335 56 79 55 36'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}