Impact of Three Probabilistic Antibiotic Therapy on Digestive Microbiota and Colonization With Multi-resistant Bacteria

Starting soon · Not applicable

Conditions studied: Osteoarticular Material Infection

In brief

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).

Key facts

Study ID

NCT07058415

Run by

Centre Hospitalier Universitaire de Nice

People needed

75

Starts

2026-07-01

Expected to finish

2027-05-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Signature of informed consent
• Negative pregnancy test for women of childbearing age.

You may not qualify if…

• 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.
• Previous surgical resection of small intestine or colon.
• Hypersensitivity to daptomycin or any of its excipients.
• Hypersensitivity to cefepime or any of its excipients or to other beta-lactamins.
• Hypersensitivity to piperacillin+tazobactam or to any of the excipients or to other beta-lactamines.
• Hypersensitivity to ceftobiprole or to any of the excipients or to other beta-lactamines.
• Renal insufficiency with GFR < 50ml/min/1.73 m2 (CKD-EPI).
• Treatment with bosentan.
• Treatment with probenecid.
• Pre-existing seizure disorder.
• Contraindication to L-arginine, acidosis, hyperkalemia that cannot be corrected.
• Treatment with HMG-CoA reductase inhibitors.
• Treatment with statins (pitavastin, pravastatin, rosuvastatin) or glyburide.
• Patients in a medical emergency.
• Pregnant or breast-feeding women.
• Patient participating in another ongoing trial.
• Mental state rendering the patient incapable of understanding this research.
• Patient deprived of liberty by administrative or judicial decision.

Where it is running

• Ch Antibes — Antibes, France
• Ch Cannes — Cannes, France
• Ch Grasse — Grasse, France
• CHU de NICE — Nice, France

Full record on ClinicalTrials.gov

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