Bone and Joint Infection
Conditions
Keywords
infection, bone and joint infection, relapse, adverse event
Brief summary
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.
Interventions
None listed
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with bone or joint infection, with or without implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Failure in patients with bone or joint infection | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of serious adverse events in patients with bone or joint infection | 6 months | 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. |
Countries
France
Contacts
Primary ContactEugénie Mabrut, ARC
Backup ContactTristan Ferry, MD, PhD
Outcome results
None listed