Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT05660733
Status:
RECRUITING
Last Update Posted:
2025-08-08
First Post:
2022-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of the Aortic and Large Arterial Vessel Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D000785', 'term': 'Aneurysm, Infected'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-19', 'lastUpdatePostDateStruct': {'date': '2025-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'one-year mortality', 'timeFrame': 'one year after the diagnosis', 'description': 'Study of all-cause mortality in patients with aortic vascular infection and large arterial vessels during the first year of follow-up after diagnosis.'}], 'secondaryOutcomes': [{'measure': 'Identification of prognostic factors associated with arterial vascular infections', 'timeFrame': 'at the time of diagnosis and up to one year afterwards', 'description': 'Identification of prognostic factors in patients with aortic and large arterial vessel infection: a multivariate Cox model to identify factors associated with mortality or better survival'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Infections and Inflammations', 'Mycotic Aneurysm', 'Arterial Infections and Inflammations', 'Prosthetic Infection']}, 'referencesModule': {'references': [{'pmid': '40377031', 'type': 'DERIVED', 'citation': 'Lalevee L, Serguei M, Jeanbert E, Simon M, Luc A, Settembre N, Henard S, Novy E, Guerci P, Lefevre B. Characteristics and outcomes of patients with infective native aortic aneurysm or vascular graft and endograft infection. Infect Dis (Lond). 2025 Oct;57(10):920-932. doi: 10.1080/23744235.2025.2502826. Epub 2025 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Aortic or large arterial vessel infections are rare but serious infections. Their management is based on French and American expert opinions. The quality of evidence supporting these guidelines is low because most publications on the subject correspond to case series and few interventional studies have been performed to validate their management. However, referral centres for vascular surgery are frequently solicited to give their opinion on patients suffering from mycotic aneurysms. In addition, the last few decades have seen the improvement of vascular surgery techniques allowing the management of more and more patients, often elderly and comorbid. There has therefore been an increase in the incidence of infectious complications associated with this care. It is therefore essential to participate in research on aortic and large arterial vessel infections. For this, a monocentric cohort study seems to be an essential first step to better understand the polymorphism and complexity of these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adults patients with proved aortic or large arterial vessel infection and without exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Aortic or large arterial vessel infection. The diagnosis is made on a number of criteria in favour of the diagnosis (at least 2 of the following 3 criteria):\n\n * Compatible clinical presentation: local or general inflammatory signs suggestive of a deep infection (fever, chills, scar discharge, fistula, febrile abdominal pain and low back pain, ...) or per-operative finding of an infection in contact with native or prosthetic vascular tissue\n * And/or biological (inflammatory syndrome) and/or imaging evidence (infectious sign on native, bioprosthetic or prosthetic vascular tissue on CT and/or PET scan) in favour of the diagnosis\n * And/or microbiological evidence (positive serologies, blood cultures or deep samples in favour of infection)\n\nExclusion Criteria:\n\n* Patient who objected to participation in this protocol and data collection\n* Pregnant woman, parturient or breastfeeding mother\n* Person deprived of liberty by a judicial or administrative decision,\n* Person subject to psychiatric care by virtue of articles L.3212-1 and L.3213-1 of the French public health code\n* Person subject to a legal protection measure\n* Person unable to give consent'}, 'identificationModule': {'nctId': 'NCT05660733', 'acronym': 'Repia', 'briefTitle': 'Study of the Aortic and Large Arterial Vessel Infections', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'French Registry Studying the Characteristics and Prognosis of Aortic and Large Arterial Vessel Infections', 'orgStudyIdInfo': {'id': 'Research on existing data'}}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'state': 'Lorraine', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lefevre Benjamin, M.D.', 'role': 'CONTACT', 'email': 'b.lefevre@chru-nancy.fr', 'phone': '+33383157654'}], 'facility': 'Université de Lorraine, CHRU Nancy and APEMAC', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'centralContacts': [{'name': 'Lefèvre Benjamin, M.D.', 'role': 'CONTACT', 'email': 'b.lefevre@chru-nancy.fr', 'phone': '+33383157654'}], 'overallOfficials': [{'name': 'Lefèvre Benjamin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Lorraine & CHRU de Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'LEFEVRE Benjamin', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}