- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05007405
Spectrum of Bacterial Infections in Rheumatology (SIBERIE)
Spectrum of Bacterial Infections in Rheumatology and the Role of Urinary Tract Infection
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 :
- To describe sites, type of micro-organism, clinical data, origin of infection, therapeutic modalities et outcome
- To compare OAI of urinary origin with those with another origin
Study Overview
Detailed Description
This retrospective study will be conducted on medical files. Patients will be mainly selected on :
- A proved osteoarticular infection (OAI) diagnosed in the department of rheumatology of the René Dubos hospital from 1° January 2010 to 31 December 2020.
- Adult patients 18 year's old or older
- Infection proved by positive culture in the osteoarticular site and/or blood (with typical clinical and imaging features)
The followed OAI are not included :
- Infection on prosthetic joint, materiel ; post-operative OAI ; osteomyelitis
- Brucellosis ; Lyme disease
Patients are selected from the codification of the hospitalization ; medical files are reviewed by the investigators.
OAI 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.
- Characteristics of three populations will be compared :
- - OAI of urinary origin
- - OAI of another origin (skin, etc)
- - 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Pontoise, France, 95300
- Department of Rheumatology, Hospital René Dubos, Pontoise
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subject aged 18 years and over at the time of diagnosis
- 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),
- Diagnosed between 01/01/2010 and 12/31/2020 (11 years)
- Hospitalization in the rheumatology department of CH René Dubos, Pontoise
Exclusion Criteria:
- Bacterial infection due to the following germs: mycobacteria, brucella, Borrelia
- Early infection on joint prosthesis
- Peripheral osteomyelitis
- Osteoarticular infection without bacteriological proof
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Osteoarticular infections
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
|
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
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of the spectrum of osteoarticular infections in adult, in a rheumatology department
Time Frame: Through study completion, an average of 1 year
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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
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Through study completion, an average of 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of urinary origin in osteoarticular infections in adults, compared with other origins
Time Frame: Through study completion, an average of 1 year
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The second purpose of this database is to identify the characteristics of osteo-articular infections of urinary origin
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Through study completion, an average of 1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Edouard Pertuiset, Dr, Centre Hospitalier Rene Dubos
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRD 1820
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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