Spectrum of Bacterial Infections in Rheumatology (SIBERIE)

January 25, 2022 updated by: Centre Hospitalier René Dubos

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

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Pontoise, France, 95300
        • Department of Rheumatology, Hospital René Dubos, Pontoise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Osteoarticular infections

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
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
Through study completion, an average of 1 year

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
The second purpose of this database is to identify the characteristics of osteo-articular infections of urinary origin
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Edouard Pertuiset, Dr, Centre Hospitalier Rene Dubos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 16, 2021

Study Record Updates

Last Update Posted (Actual)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 25, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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