Lyon BJI Cohort Study

Study Overview
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Brief Summary
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The prospective Cohort includes all patients with bone or joint infection (BJI), with or without implant. The aim of this Cohort is to improve the knowledges about the treatment failure and the occurrence of serious adverse events. Various data of patients included are collected and will be analysed. Patients with a bone or joint infection are treated at the department of infectious diseases, at Infectious disease department of Hospices Civils de Lyon. They have regularly a consultation with a physician: 2-3 weeks after surgery, 6 weeks after surgery, 3 months after surgery, 6 months after surgery, 12 months after surgery and 24 months after surgery. It allows to the physician to follow the evolution of the patient under treatment and after discontinuation of the treatment. Several data are collected during the follow-up concerning: demographics data, treatment including the use of off-label antibiotics for the treatment of BJI, adverse events, microbiology, surgeries, healing or relapse, date of symptoms, ASA score, implant or not. If there is an implant, the date of implantation and the number of the prosthesis infected are collected. This cohort allows to improve knowledge concerning the treatment failure and the occurrence of adverse events.

Official Title
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Lyon BJI Cohort Study

Conditions
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Bone and Joint Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with bone or joint infection, with or without implant

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Failure in patients with bone or joint infection | Up to 30% of patients experience a relapse, even when the treatment is considered as optimal. This Cohort will improve knowledges about the mechanisms of treatment failure by collecting data concerning infectious disease, surgery and microbiology and by analysing the cases where treatment failed. Treatment failure is defined by local clinical and/or microbiological relapse, under treatment or after treatment discontinuation. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of serious adverse events in patients with bone or joint infection | The duration of the antibiotic treatment is long : several weeks, several months or even several years in some cases. Patients are then exposed to adverse events. The data concerning theses adverse events are collected in this Cohort : molecule, dosage, description of the adverse event, a change in treatment. A severity grade is allocated to every adverse event, based on the  Common Terminology Criteria for Adverse Events . This is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term (from 1 to 5). Severe adverse events have a grade >=3. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infection, bone and joint infection, relapse, adverse event