Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT05521035
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2022-08-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk and Incidence of Aortic Graft and Endograft Infection With BSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aortic vascular graft or endograft infection', 'timeFrame': 'At least 1 year follow-up', 'description': 'Determined by the MAGIC-criteria'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Infections and Inflammations']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/26804214/', 'label': 'Treatment and outcomes of aortic endograft infection'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27771318/', 'label': 'Diagnosis of Aortic Graft Infection: A Case Definition by the Management of Aortic Graft Infection Collaboration (MAGIC)'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/19097807/', 'label': 'Secondary infections of thoracic and abdominal aortic endografts'}]}, 'descriptionModule': {'briefSummary': 'What is the risk of aortic vascular graft and endograft infection in patients with aortic vascular graft/endograft and bloodstream infection?', 'detailedDescription': 'All patients with previous aortic vascular graft and endograft surgery between years 2010 and 2021 in four regions of south Sweden (Skåne, Halland, Kronoberg and Blekinge) will be included in the study. These patients will be evaluated for bloodstream infection (BSI) or not. For all patients with BSI, the risk of aortic vascular graft and endograft infection will be investigated. Aortic vascular graft and endograft infection will be determined by usage of the MAGIC-criteria.\n\nRisk factors for developing aortic vascular graft and endograft infection will be investigated, and if possible used to construct a risk score. This risk score could be used by clinicians to determine if bacteremic patients with aortic vascular grafts or endografts should be evaluated for aortic vascular graft and endograft infection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with previous aortic vascular graft or endograft surgery in Skåne, Halland, Kronoberg and Blekinge between the years 2010-2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrevious aortic vascular graft or endograft infection with bloodstream infection.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT05521035', 'briefTitle': 'Risk and Incidence of Aortic Graft and Endograft Infection With BSI', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Risk and Incidence of Aortic Graft and Endograft Infection in Patients With Bloodstream Infection, a Population Based Study in South Sweden', 'orgStudyIdInfo': {'id': '2022-5-BSI'}}, 'contactsLocationsModule': {'locations': [{'city': 'Helsingborg', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Adam Cewers', 'role': 'CONTACT'}], 'facility': 'Helsingborgs lasarett', 'geoPoint': {'lat': 56.04673, 'lon': 12.69437}}], 'centralContacts': [{'name': 'Oskar Ljungquist, M.D, PhD', 'role': 'CONTACT', 'email': 'oskar.ljungquist@med.lu.se', 'phone': '+46424061000'}, {'name': 'Torgny Sunnerhagen, M.D, PhD', 'role': 'CONTACT', 'email': 'torgny.sunnerhagen@med.lu.se'}], 'overallOfficials': [{'name': 'Oskar Ljungquist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'If individual participant data (IPD) will be shared, it will be after researchers has been given ethical approval'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}