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Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

RecruitingPhase 3Ages 18 Years - anyAllTourcoing Hospital
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In plain words

What the trial is, and whether it could suit you

Rifampicin, is key in the treatment of staphylococcal PJIs. Rifabutin has a better profile of tolerance than rifampicin regarding the risk of interaction with concomitant medications and liver disorders. The hypothesis is that rifabutin may be an alternative antibiotic option as efficient as rifampicin for the treatment of staphylococcal PJIs, with a better safety profile. The investigator aim to demonstrate the non-inferiority of rifabutin as compared with rifampicin prescribed in combination treatment for PJIs.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy) 2. Infected with at least one of the following microorganisms: 1. Staphylococcus aureus 2. Coagulase-negative staphylococci 3. Microorganisms susceptible to rifampicin and at least one other antibiotic suitable for the treatment of PJI (e.g., penicillin, fluoroquinolone, (doxy/mino)cycline, oxazolidinone, cotrimoxazole, daptomycin, glycopeptide, macrolide, fusidic acid), regardless of sensitivity to methicillin. 4. Age ≥ 18 years 5. At least 2 days of appropriate (i.e., covering pathogen(s) identified in the intraoperative samples) empirical agents are needed. Pre-randomization antimicrobial therapy could be: flucloxacillin, oxacillin, vancomycin, daptomycin. β-lactam plus β-lactamase-inhibitors (e.g. ampicillin+sulbactam, piperacillin+tazobactam), cephalosporins (except ceftazidime), carbapenems, teicoplanin, ceftaroline, ceftobiprole. 6. Signed Inform consent 7. Patient having the rights to French social insurance 8. For women of childbearing potential i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile and excluding oestroprogestative-based contraception, any effective contraceptive: vasectomy (for men), intrauterine device copper, feminine sterilization, condom, sexual abstinence is required. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause Exclusion Criteria: 1. Suspicion of reduce absorption of oral treatment due to abdominal disorder Known or suspected malabsorption (imperfect absorption of food material by the small intestine) 2. Polymicrobial infection due to other than staphylococcus species susceptible to rifampicin 3. Known or suspected allergy to rifabutin and/or rifampicin 4. Diagnosis of endocarditis associated to PJI 5. Renal transplant or Chronic kidney disease with an eGFR of less than 30ml/min/1.73m² 6. Other Solid Organ Transplant 7. Liver cirrhosis, Child-Pugh score C 8. Any other concomitant infection which required a prolonged course of intravenous antibiotic therapy 9. Oestroprogestative-based contraception 10. Oral anticoagulant drugs 11. Other drug-drug interaction that contraindicated rifampicin or rifabutin 12. Porphyria 13. Unable to take oral treatment 14. Receive empirical postoperative antibiotic treatment by rifampicin or rifabutin prior to randomization 15. Pregnancy or lactating women 16. Curator or guardianship or patient placed under judicial protection 17. Participation in other interventional research during the study
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What it tests

  • Rifabutin
  • Rifampicin
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Where

30 sites
CHU Amiens Picardie
Amiens, France
CHU Angers
Angers, France
CHU Besançon
Besançon, France
CH de Béthune
Béthune, France
CHU Bordeaux
Bordeaux, France
APHP Hôpital Ambroise Paré
Boulogne-Billancourt, France
CHRU Brest
Brest, France
CHU Caen
Caen, France

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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