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

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jul 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how three different antibiotic treatments affect the balance of bacteria in the digestive system and the presence of hard-to-treat bacteria in patients who have infections related to joint or bone implants, such as hip or knee replacements. After surgery to fix or replace these implants, doctors often give antibiotics right away to prevent or treat infection, but it’s not clear which antibiotic works best without harming the helpful bacteria in the body. This study compares three antibiotic combinations to see how they impact patients’ gut bacteria and the chance of carrying resistant bacteria.

Adults aged 18 and older who need surgery to revise or fix joint implants because of suspected infection might be eligible to join. To participate, patients need to have normal muscle enzyme levels, be covered by social security, and agree to the study with informed consent. People who recently took antibiotics, have certain infections or medical conditions, or are pregnant or breastfeeding will not be eligible. If accepted, participants will receive one of the three antibiotic treatments after their surgery, and researchers will monitor how these medicines affect their digestive bacteria and resistance to infection. This study is not yet recruiting, but it aims to help doctors choose antibiotics that protect patients’ health while fighting infection effectively.

Gender

ALL

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.