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In the event of suspected osteoarticular material infection (OAMI), broad-spectrum probabilistic antibiotic therapy is recommended immediately after revision surgery. There are no efficacy data to suggest that any particular to favour any particular molecule. However, the choice may depend on the impact on the microbiota and on Enterobacteriaceae colonization with multi-resistant Enterobacteriaceae. Our aim is to evaluate three different strategies efepime+daptomycin C+D, piperacillin-tazobactam+daptomycin (PT+D) and ceftobiprole (CFB).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Céfépime + Daptomycine | Active Comparator | First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). |
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| Pipéracilline-Tazobactam + Daptomycine | Active Comparator | First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). |
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| Ceftobiprole | Experimental | First stool sample taken the day before starting antibiotic therapy. Second stool sample on the fourth post-operative day (D5). Third stool sample taken 28 days after the end of antibiotic treatment (DX+28). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool sample 1 | Other | Stool sampling at D0 for having baseline reference |
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| Measure | Description | Time Frame |
|---|---|---|
| Compare changes in gut microbiota biodiversity between Day1 and Day5 between populations treated with C+D, PT+D and CFB in suspected Osteoarticular infection on equipment | using targeted metagenomics (16S rDNA) | At Day 5 after starting treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the evolution between Day1/end of treatment+28 Days and between Day 5/end of treatment+28D of microbiota biodiversity of each patient population treated with different antibiotics for suspected Osteoarticular infection on equipment | Simpson index, | Up to 4 months |
| Compare the rate of acquisition of multidrug-resistant extended-spectrum beta-lactamase-producing intestinal Enterobacteria between antibiotic strategies on samples at Day5 and DX+28 in patients with no multidrug-resistant Enterobacteria at Day1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Johan COURJON | Contact | 0492035877 | courjon@chu-nice.fr | |
| Irit TOUITOU | Contact | touitou.i@chu-nice.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ch Antibes | Antibes | France |
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Comparative, randomized, multicentric clinical trial
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| Stool sample 2 | Other | Stool sampling at D5 to study the impact of antibiotics on microbiota |
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| Stool sample 3 | Other | Stool sampling at DX+28 to study the impact of antibiotics on microbiota |
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Stool culture on a selective medium at Day1, Day5 and Day X+28 |
| Up to 4 months |
| Compare the rate of acquisition of carbapenemase-producing intestinal multi-resistant Enterobacteriaceae (EPC) between antibiotic strategies on samples taken at D5 and DX+28 in patients with no multi-resistant Enterobacteria at D1. | The appearance of EPC-type multi-resistant Enterobacteriaceae will be determined by stool culture on a selective medium selective medium (mSuperCARBA, MAST diagnostic) at D1, D5 and DX+28. | Up to 4 months |
| Comparison of the rate of inadequacy of probabilistic strategies in the event of retained infection. | Inadequacy of one of the three probabilistic strategies will be defined by a documented infection with a bacterium resistant to both antibiotics in the case of dual therapy, or to ceftobiprole in the case of monotherapy. | Up to 4 months |
| Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks. | Shannon index | Up to 4 months |
| Compare the evolution between J5/JX+28 of microbiota biodiversity of patients receiving no antibiotic treatment for infection and patients in whom an infection is detected, with antibiotic treatment prescribed for 6 to 12 weeks. | Piélou equitability index | Up to 4 months |
| Ch Cannes | Cannes | France |
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| Ch Grasse | Grasse | France |
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| CHU de NICE | Nice | France |
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