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| Name | Class |
|---|---|
| Hospices Civils de Lyon | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed | Patients with a monomicrobial S. aureus orhtopaedic device-related infection who have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7). Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research. |
| |
| Not Exposed | Patients with a monomicrobial S. aureus orhtopaedic device-related infection who not have received antibiotherapy able to prevent biofilm formation following surgical intervention (from day 0 to day 7). Upon inclusion, antibiograms were performed on the S. aureus isolated as part of routine procedure. S. aureus isolates was further analysed via an Antibiofilmogramme, which is an experimental element added by this research. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antibiofilmogramme | Diagnostic Test | An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate. |
| Measure | Description | Time Frame |
|---|---|---|
| Success or treatment failure | 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. | From surgical intervention to one year after the end of antimicrobial therapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Age | (years) | Baseline (Day 0) |
| Sex | (m/f) | Baseline (Day 0) |
Inclusion Criteria:
Exclusion Criteria:
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The study population is composed of patient with a monomicrobial S. aureus orthopaedic device-related infections.
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| Name | Affiliation | Role |
|---|---|---|
| Frederic Laurent, PharmD - PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon | Lyon | 69004 | France |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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The S. aureus strains isolated will be maintained in a collection for future ancillary studies.
| Body mass index |
(kg/m²) |
| Baseline (Day 0) |
| Charlson Comorbidity Index | (0-37) | Baseline (Day 0) |
| Localization of the infection | Knee, Hip or other | Baseline (Day 0) |
| Orthopaedic device | Prothesis, screw, plate or other | Baseline (Day 0) |
| Time of onset of symptoms | (date) | Baseline (Day 0) |
| Time of microbiological diagnostics | (date) | Baseline (Day 0) |
| Time of implantation of the device | (date) | Baseline (Day 0) |
| Microbiological analysis | Number of positive S. aureus biopsy samples | Baseline (Day 0) |
| Antibiogram results | Qualitative results per antibiotic type and dose: classification as sensitive, intermediate, resistance and MIC estimation by the Vitek | Baseline (Day 0) |
| Surgical Therapy | Conservative treatment (arthrotomy, debriedment, synovectomy) or removal of implant (one stage, two stage) | Baseline (Day 0) |
| Antibiotics taken | Name of the molecule, dose and duration | through study completion, an average of 1 year |