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difficulties in including patients with Staphylococcus aureus infection
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There are more than one million (> 40,000 cases per year in France) of osteoarticular infections (OAI) yearly in the world. The number of these infections is constantly increasing due to an increase in life expectancy associated with an increase in prosthesis fitting, as well as an increase in comorbid factors. These are severe pathologies associated with mortality (5%) and significant morbidity (40%), responsible for functional sequelae with an individual cost (prolonged hospitalization, altered quality of life, disability) and societal (sick leave, partial disability). or total, temporary or permanent) extremely high. In addition, reinfection rates within two years of treatment are high.
The BJIs are a group of clinical entities that have in common the invasion and progressive destruction of bone and cartilage tissue by bacterial-like microorganisms.
Staphylococcus spp is the main pathogen (>50%) in BJI and is associated with particularly difficult to treat infections, with a high rate of chronicity and relapses, especially in case of implanted material.
The difficulty in managing these infections is partly linked, on the one hand, to the fact that the pathogens are in "persistent" metabolic forms and in intracellular reservoirs which make them insensitive to conventional antibiotics and, on the other hand, the absence of reliable markers of the infection and above all of its clinical resolution, which complicates clinical trials.
ESPRI-IOAC is a consortium of 4 partners (private-public) from Lyon area and which aims at:
The current study is part of the global ESPRI-IOAC consortium, and represent the clinical application.
It is a prospective study of patients treated for BJI in the infectious disease department of the Hospices Civils de Lyon, La Croix-Rousse, for osteo-articular infections due to Staphylococcus aureus, or for simple mechanical revision or for cruciate ligament surgery, the objective of which is to highlight biomarkers of interest in the diagnosis of chronic BJI and, or predictive of the therapeutic response.
The translational value of the experimental models used in the BJI will also be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BJI group | Patients with an BJI on material (prosthesis or other implant) infected by Staphylococcus aureus* Patients are follow-up during two years after surgery. *Diagnosis of staphylococcus aureus monoinfection realized a posteriori after surgery on bacteriological sample |
| |
| Control Group With material | Patients with mechanical problems on implanted equipment (control cohort), without infection* Patient of this group are follow-up until surgery. *Diagnosis of staphylococcus aureus monoinfection realized a posteriori after surgery on bacteriological sample |
| |
| Group osteomyelitis | Patients with chronic osteomyelitis* Patient of this group are follow-up until surgery. *Diagnosis of staphylococcus aureus monoinfection realized a posteriori after surgery on bacteriological sample |
| |
| Control Group with cruciate ligament surgery | Patients having cruciate ligament surgery Patient of this group are follow-up until surgery. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Constitution of serum bank at D0 | Other | Blood samples at Day 0 (day of surgery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dosages of serum osteocalcin | Comparison of dosages by ELISA test of serum osteocalcin between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI. | At the time of surgery |
| Dosages of serum procollagen propeptide type 1 | Comparison of dosages by ELISA test of serum procollagen propeptide type 1 between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI. | At the time of surgery |
| Dosages of serum cross-linked telopeptide of type 1 collagen | Comparison of dosages by ELISA test of serum cross-linked telopeptide of type 1 collagen between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI. | At the time of surgery |
| Dosages of serum periostin | Comparison of dosages by ELISA test of serum periostin between the patients with OAI and the "control" patients without OAI at the time of inclusion in order to demonstrate a marker or a combination of markers for OAI. | At the time of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated in the orthopedic surgery and infectious diseases departments of the Hospices Civils de Lyon, Croix-Rousse Hospital, for osteo-articular infections, due to Staphylococcus aureus, for simple mechanical revision or for cruciate ligament surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Tristan FERRY, Pr | Service Maladies Infectieuses et Tropicales, CRIOAC Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Croix Rousse | Lyon | 69004 | France |
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| Constitution of serum bank during follow-up | Other | Blood samples are obtained at week 2, week 6 post-surgery, at the end of antibiotherapy and 6 months post-surgery, only for patients with staphylococcus aureus monoinfection who are follow-up during two years. |
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| ELISA assays of serum markers of bone remodeling at D0 | Other | Assessment by ELISA assays of serum markers of bone remodelling: the osteocalcin (OC), the procollagen propeptide type 1 (PINP), the cross linked telopeptide of type 1 collagen (CTX1) and the periostin at Day 0 (day of surgery) |
|
| ELISA assays of serum markers of bone remodeling during follow-up | Other | Assessment by ELISA assays of serum markers of bone remodelling: the osteocalcin (OC), the procollagen propeptide type 1 (PINP), the cross linked telopeptide of type 1 collagen (CTX1) and the periostin at week 2, week 6 post-surgery, at the end of antibiotherapy and 6 months post-surgery, only for patients with staphylococcus aureus monoinfection who are follow-up during two years |
|
| Analysis of bacterial gene expression at D0 | Other | Assessement of bacterial gene expression on surgery residual tissue (bone tissue, joint fluid, fragment of prostheses) collected at Day 0 (day of the surgery) |
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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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