Evaluation of the Antibiofilmogramme Test During Orthopaedic Device-Related Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Demonstration of Clinical Value of Antibiofilmogramme Test for Monomicrobial S. Aureus Orthopaedic Device-Related Infection

Conditions
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Prosthetic Joint Infection, Staphylococcus Aureus, Biofilm

Intervention / Treatment
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* Diagnostic Test: Antibiofilmogramme


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed<br>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. | Diagnostic Test: Antibiofilmogramme<br>* An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.<br>|
| Not Exposed<br>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. | Diagnostic Test: Antibiofilmogramme<br>* An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiogramme, Antibiofilmogramme