Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 9:18 PM
Study NCT ID:
NCT07305402
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vascular Infections Caused by Coxiella Burnetii
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'two-year mortality rate', 'timeFrame': '2 years', 'description': 'from the time of initial management'}], 'secondaryOutcomes': [{'measure': 'Early mortality rate', 'timeFrame': 'Day 30', 'description': 'Early mortality rate (Day 30)'}, {'measure': 'Infection-attributed mortality rate', 'timeFrame': '2 years', 'description': 'Infection-attributed mortality rate'}, {'measure': 'Two-year morbidity rate', 'timeFrame': '2 years', 'description': 'Two-year morbidity rate'}, {'measure': 'Rate of initial complications', 'timeFrame': '2 years', 'description': 'Rate of initial complications'}, {'measure': 'Rate of postoperative complications', 'timeFrame': '2 years', 'description': 'Rate of postoperative complications'}, {'measure': 'Diagnostic performance of the different imaging modalities', 'timeFrame': '2 years', 'description': 'Diagnostic performance of the different imaging modalities'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vascular infection', 'vascular graft infection', 'vascular endograft infection', 'Coxiella burnetii'], 'conditions': ['Vascular Infection Caused by C. Burnetii']}, 'descriptionModule': {'briefSummary': 'high morbidity and mortality. In France, Coxiella burnetii-related vascular infections appear to be increasing, though data remain limited. Two-year mortality reaches 15-18%, mainly due to serious complications such as arterio-digestive fistulas. Diagnosis is often delayed, prognostic factors are poorly defined, and the value of advanced imaging techniques remains insufficiently studied.', 'detailedDescription': 'Q fever is a worldwide zoonosis that may cause chronic vascular infections with significant morbidity and mortality. In France, the incidence of Coxiella burnetii-related vascular infections appears to be increasing, although published data remain scarce. Reported two-year mortality reaches 15-18%, largely due to severe complications such as arterio-digestive fistulas. Classical risk factors include aortic aneurysm and vascular grafts, but many patients present without clear zoonotic exposure, leading to frequent underdiagnosis. Prognostic factors are poorly defined, apart from the lack of surgical management, which worsens outcomes. Diagnosis is often delayed, and the value of advanced imaging modalities such as 18F-FDG PET/CT or labeled leukocyte scintigraphy remains insufficiently studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults (≥ 18yrs old) with native or prosthetic vascular infection due to C. burnetii', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥ 18yrs old) with native or prosthetic vascular infection due to C. burnetii (Jan 2000 - Dec 2023)\n* diagnosis based on CNR vascular Q fever criteria,\n* supplemented by MAGIC (Management of Aortic Graft Infection Collaboration) criteria for prosthetic/ - endovascular infections or aortitis/arteritis criteria,\n* no objection to reuse of patient data.\n\nExclusion Criteria:\n\n* patient under legal protection,\n* insufficient French language comprehension'}, 'identificationModule': {'nctId': 'NCT07305402', 'acronym': 'COXIVAS', 'briefTitle': 'Vascular Infections Caused by Coxiella Burnetii', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'A French Multicenter Retrospective Study of Native and Prosthetic Vascular Infections Caused by Coxiella Burnetii (COXIVAS)', 'orgStudyIdInfo': {'id': 'CHUBX 2025/024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Prosthetic vascular infection due to C. burnetii', 'description': 'Adults with native or prosthetic vascular infection due to C. burnetii'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bordeaux', 'country': 'France', 'contacts': [{'name': 'Mathilde Puges, MD', 'role': 'CONTACT', 'email': 'mathilde.puges@chu-boreaux.fr', 'phone': '+335 56 79 55 36'}, {'name': 'Zoe Blanc, MD', 'role': 'CONTACT', 'email': 'zoe.blanc@chu-bordeaux.fr'}], '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'}, {'name': 'Zoe Blanc, MD', 'role': 'CONTACT', 'email': 'zoe.blanc@chu-bordeaux.fr', 'phone': '+335 56 79 55 36'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}