About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Indication for prosthetic revision (PTG, PUC, PTH or hip hemiarthroplasty, PTE) or internal osteosynthesis with suspicion of IOAM following the opinion of a Réunion de concertation Pluridisciplinaire (RCP) on complex osteoarticular infections
Normal CPK level according to laboratory standard
Social security affiliation
Disqualifiers
Antibiotic therapy in the 3 months prior to inclusion
Clinical or radiological signs making HAI highly probable: scar discharge and/or peri-scar cellulitis fistula or abscess, bacteremia
positive bacterial culture from joint puncture or biopsy prior to revision
Chronic inflammatory bowel disease.
Trial design
Parallel
Treatments tested in this trial
Stool sample 1
Other interventionStool sampling at D0 for having baseline reference
Stool sample 2
Other interventionStool sampling at D5 to study the impact of antibiotics on microbiota
Stool sample 3
Other interventionStool sampling at DX+28 to study the impact of antibiotics on microbiota
Treatment groups
Trial outcomes
Primary outcomes
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)
Secondary outcomes
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,
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.
Stool culture on a selective medium at Day1, Day5 and Day X+28
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.
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.
Sponsors and contacts
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