Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2026-01-04 @ 4:21 PM
Study NCT ID:
NCT06425250
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002169', 'term': 'Campylobacter Infections'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012307', 'term': 'Risk Factors'}], 'ancestors': [{'id': 'D012306', 'term': 'Risk'}, {'id': 'D011336', 'term': 'Probability'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D015984', 'term': 'Causality'}, {'id': 'D015981', 'term': 'Epidemiologic Factors'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2024-05-17', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Outcome of Campylobacter spp. BJI, measured as the proportion of treatment failure.', 'timeFrame': 'Outcome will be measure at 1 year. For patients lost of follow-up or followed-up less than a year, the date of last visit will be used for survival curve analysis .', 'description': 'Treatment failure will be defined as: i) infection persistence under appropriate antimicrobial therapy; ii) infection relapse; iii) need for unplaned surgery; iv) superinfection and/or v) infection-related death'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Management', 'Risk factors', 'Campylobacter spp.'], 'conditions': ['Campylobacter Infections']}, 'descriptionModule': {'briefSummary': 'Campylobacter bacteria, a Gram-negative bacillus commensal in the digestive tract of many animals and mainly responsible for human infections with digestive origins, has been little studied in the field of osteoarticular infections (OAI). Campylobacter spp. are, however, well described, mainly for C. fetus, and pose a dual therapeutic problem: i) a capacity for persistence due to the capacity of most strains to form biofilm; and ii) potential resistance to many antibiotics. The management of IOA caused by Campylobacter spp. is not codified, and is based on small series of cases reported in the literature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* Osteoarticular infection (whatever its type), mono or polymicrobial with Campylobacter spp., diagnosed between 01/01/2013 and 12/31/2022:\n* Septic arthritis: compatible clinical signs + joint fluid sample positive in culture and/or PCR positive for Campylobacter\n* Spondylodiscitis: clinical signs and MRI compatible + blood cultures and/or disco-vertebral biopsy puncture positive in culture and/or PCR positive for Campylobacter\n* Osteitis/osteomyelitis: compatible clinico-radiological picture + bone sample (biopsy or intraoperative sample) positive in culture and/or positive PCR for Campylobacter\n* Infection on joint prosthesis or osteosynthesis equipment: documented Campylobacter infection and meeting the definition of probable or confirmed JIBS infections\n* Patient who was informed and did not object to participating in the study\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06425250', 'acronym': 'Campylo-BJI', 'briefTitle': 'Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Campylobacter Spp. Bone and Joint Infection: a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '69HCL23_5284'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Management, progression and risk factors for failure of BJI caused by Campylobacter spp.', 'description': 'Adult patients treated for prosthetic joint infection caused by Campylobacter spp. between 01/01/2013 and 12/31/2022', 'interventionNames': ['Other: Management, progression and risk factors for failure of BJI caused by Campylobacter spp.', 'Other: Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.']}], 'interventions': [{'name': 'Management, progression and risk factors for failure of BJI caused by Campylobacter spp.', 'type': 'OTHER', 'description': 'Description of demographic data (sex, age), comorbidities (ASA and Charlson scores), orthopedic and septic history, and surgical and medical management (antibiotic therapy)', 'armGroupLabels': ['Management, progression and risk factors for failure of BJI caused by Campylobacter spp.']}, {'name': 'Description of the evolution and risk factors for failure of osteoarticular infections caused by Campylobacter spp.', 'type': 'OTHER', 'description': 'Failure of treatment: defined according to a composite criterion bringing together\n\n* persistence of the infection under treatment, and/or\n* recurrence of the infection after stopping antibiotic therapy, and/or\n* need for surgical revision for septic reasons more than 5 days after initial treatment, and/or\n* superinfection, and/or\n* definitive explantation of the material, and/or\n* decision for suppressive antibiotic therapy, and/or\n* amputation, and/or\n* death linked to infection', 'armGroupLabels': ['Management, progression and risk factors for failure of BJI caused by Campylobacter spp.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69317', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Florent VALOUR, Dr', 'role': 'CONTACT', 'email': 'florent.valour@chu-lyon.fr', 'phone': '04 72 07 11 07', 'phoneExt': '+33'}], 'facility': 'Service des maladies infectieuses et tropicales - Hôpital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}