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ClinicalTrials.gov ID

NCT07058415

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

75Estimated

Last Update Posted

Jun 22, 2026Actual

Start Date

Jul 2026Estimated

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

Official Title

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

Brief Summary

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).

• Osteoarticular Material Infection

• Stool sample 1
• Stool sample 2
• Stool sample 3

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

n.doux@ch-cannes.fr

ge.gozzerino@ch-grasse.fr

Touitou.i@chu-nice.fr