Biofilm, Prosthetic Joint Infection, Staphylococcus Aureus
Conditions
Keywords
Antibiogramme, Antibiofilmogramme
Brief summary
This is an observational study that does not change routine care. The primary objective of this study is to investigate the correlation between the administration of an antibiotherapy able to prevent biofilm formation according to the results of the Antibiofilmogramme test, and the relapse of the infection for patient with orthopaedic device-related infection.
Detailed description
The secondary objectives are: A. Investigate the role of antibiogram-antibiofilmogramme concordance (in terms of S. aureus strains and prescribed antibiotics) in orthopaedic device-related infection management. B. Investigate the capacity of S. aureus isolates to form biofilm in presence/absence of antibiotics. C. Create an S. aureus strain collection for future ancillary studies
Interventions
DIAGNOSTIC_TESTAntibiofilmogramme
An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
Sponsors
Hospices Civils de Lyon
BioFilm Control
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have been informed and received a non-opposition consent form * Patient with a monomicrobial S. aureus bone and joint infections * Patient with prosthetic or orthopaedic device
Exclusion criteria
* Bone and joint infection from pressure ulcer, vascular injury or diabetic foot ulcer * Polymicrobial prosthetic joint infection * The patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study * Patient is under judicial protection, under tutorship or curatorship * The patient expresses his opposition to participate to the study * It is impossible to correctly inform the patient * The patient is pregnant, parturient or breastfeeding * Emergency situation precluding correct study implementation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success or treatment failure | From surgical intervention to one year after the end of antimicrobial therapy. | Presence or absence of microbiological treatment failure confirmed by S. aureus positive clinical samples. The diagnostic of a S. aureus positive clinical sample indicated a treatment failure. Treatment success corresponded to an absence of clinical or microbiological treatment failure, or treatment failure with positive clinical sample other than S. aureus. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Orthopaedic device | Baseline (Day 0) | Prothesis, screw, plate or other |
| Time of onset of symptoms | Baseline (Day 0) | (date) |
| Time of microbiological diagnostics | Baseline (Day 0) | (date) |
| Time of implantation of the device | Baseline (Day 0) | (date) |
| Microbiological analysis | Baseline (Day 0) | Number of positive S. aureus biopsy samples |
| Antibiogram results | Baseline (Day 0) | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance and MIC estimation by the Vitek |
| Antibiotics taken | through study completion, an average of 1 year | Name of the molecule, dose and duration |
| Age | Baseline (Day 0) | (years) |
| Sex | Baseline (Day 0) | (m/f) |
| Body mass index | Baseline (Day 0) | (kg/m²) |
| Charlson Comorbidity Index | Baseline (Day 0) | (0-37) |
| Localization of the infection | Baseline (Day 0) | Knee, Hip or other |
| Surgical Therapy | Baseline (Day 0) | Conservative treatment (arthrotomy, debriedment, synovectomy) or removal of implant (one stage, two stage) |
Countries
France
Outcome results
None listed