Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-31 @ 11:01 PM
Study NCT ID:
NCT05007405
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spectrum of Bacterial Infections in Rheumatology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D014552', 'term': 'Urinary Tract Infections'}], 'ancestors': [{'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2021-08-11', 'studyFirstSubmitQcDate': '2021-08-11', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of the spectrum of osteoarticular infections in adult, in a rheumatology department', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The purpose of this database is to describe the spectrum of osteoarticular infections in adults, non-tuberculosis germs, in a rheumatology department of a CHG during the 2010s'}], 'secondaryOutcomes': [{'measure': 'Prevalence of urinary origin in osteoarticular infections in adults, compared with other origins', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'The second purpose of this database is to identify the characteristics of osteo-articular infections of urinary origin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Osteoarticular infection', 'Bacteria', 'Urinary tract infections'], 'conditions': ['Articular Disease']}, 'referencesModule': {'references': [{'pmid': '28366221', 'type': 'BACKGROUND', 'citation': 'Ross JJ. Septic Arthritis of Native Joints. Infect Dis Clin North Am. 2017 Jun;31(2):203-218. doi: 10.1016/j.idc.2017.01.001. Epub 2017 Mar 30.'}, {'pmid': '26229122', 'type': 'BACKGROUND', 'citation': 'Berbari EF, Kanj SS, Kowalski TJ, Darouiche RO, Widmer AF, Schmitt SK, Hendershot EF, Holtom PD, Huddleston PM 3rd, Petermann GW, Osmon DR, Infectious Diseases Society of America. 2015 Infectious Diseases Society of America (IDSA) Clinical Practice Guidelines for the Diagnosis and Treatment of Native Vertebral Osteomyelitis in Adults. Clin Infect Dis. 2015 Sep 15;61(6):e26-46. doi: 10.1093/cid/civ482. Epub 2015 Jul 29.'}]}, 'descriptionModule': {'briefSummary': 'Retrospective study of patients with a proved non-tuberculous osteoarticular infection (OAI) diagnosed in a rheumatology department during the years 2010-2020. The objectives are :\n\n* To describe sites, type of micro-organism, clinical data, origin of infection, therapeutic modalities et outcome\n* To compare OAI of urinary origin with those with another origin', 'detailedDescription': "This retrospective study will be conducted on medical files. Patients will be mainly selected on :\n\n* A proved osteoarticular infection (OAI) diagnosed in the department of rheumatology of the René Dubos hospital from 1° January 2010 to 31 December 2020.\n* Adult patients 18 year's old or older\n* Infection proved by positive culture in the osteoarticular site and/or blood (with typical clinical and imaging features)\n\nThe followed OAI are not included :\n\n* Infection on prosthetic joint, materiel ; post-operative OAI ; osteomyelitis\n* Brucellosis ; Lyme disease\n\nPatients are selected from the codification of the hospitalization ; medical files are reviewed by the investigators.\n\nOAI of urinary origin is defined either by the same micro-organism in urine and osteo-articular sample (or blood) or a bacteria in the osteo-articular sample in conjunction with : urologic pathology, recurrent urinary tract infection, urologic surgery, antibiotic therapy.\n\n* Characteristics of three populations will be compared :\n* \\- OAI of urinary origin\n* \\- OAI of another origin (skin, etc)\n* \\- OAI without known origin Characteristics include : gender, age, risk factors, site of osteo-articular infection, type of micro-organism, type of positive sample(s), blood cultures, urinary cultures, duration of symptoms, site of primary infection and/or type of contamination, biological results, echocardiography, imaging results, type of treatment (medical, surgical), outcome, duration of hospitalization, intensive unit care stay, death at hospital."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged 18 years and over at the time of diagnosis\n* Osteoarticular infection (septic arthritis, spondylodiscitis), by a bacterium or a fungus, proven by a bacteriological sample in situ or in the blood by positive blood culture (with an unequivocal clinical, biological and imaging feature),\n* Diagnosed between 01/01/2010 and 12/31/2020 (11 years)\n* Hospitalization in the rheumatology department of CH René Dubos, Pontoise\n\nExclusion Criteria:\n\n* Bacterial infection due to the following germs: mycobacteria, brucella, Borrelia\n* Early infection on joint prosthesis\n* Peripheral osteomyelitis\n* Osteoarticular infection without bacteriological proof'}, 'identificationModule': {'nctId': 'NCT05007405', 'acronym': 'SIBERIE', 'briefTitle': 'Spectrum of Bacterial Infections in Rheumatology', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital NOVO'}, 'officialTitle': 'Spectrum of Bacterial Infections in Rheumatology and the Role of Urinary Tract Infection', 'orgStudyIdInfo': {'id': 'CHRD 1820'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Osteoarticular infections', 'description': 'Retrospective study on medical file of patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020', 'interventionNames': ['Other: Groups/Cohortes']}], 'interventions': [{'name': 'Groups/Cohortes', 'type': 'OTHER', 'otherNames': ['Osteoarticular infections'], 'description': 'Retrospective study on medical file of patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020', 'armGroupLabels': ['Osteoarticular infections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95300', 'city': 'Pontoise', 'country': 'France', 'facility': 'Department of Rheumatology, Hospital René Dubos, Pontoise', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}], 'overallOfficials': [{'name': 'Edouard Pertuiset, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital NOVO'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital NOVO', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}