Comparing Rifabutin and Rifampicin for Staphylococcal Joint Infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness and safety of rifabutin versus rifampicin in treating prosthetic joint infections (PJIs) caused by staphylococcal bacteria. The study will involve patients who have undergone debridement and are receiving antibiotic therapy while retaining their prosthesis. The hypothesis is that rifabutin may provide similar efficacy to rifampicin but with a better safety profile, particularly regarding drug interactions and liver health. Participants will be monitored to assess the non-inferiority of rifabutin in this context.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Besançon
  Besançon, France Recruiting
• CHRU Brest
  Brest, France Recruiting
• CHU Caen
  Caen, France Recruiting
• CHRU Lille
  Lille, France Recruiting
• CHU de Limoges
  Limoges, France Recruiting
• CH Annecy Genevois
  Pringy, France Recruiting

Study contacts

• Principal investigator: Eric SENNEVILLE, Md PhD — Ch Tourcoing
• Study coordinator: Eric SENNEVILLE, MD PhD
• Email: esenneville@ch-tourcoing.fr
• Phone: 0320694949

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding infections in aortic and large arterial vessels

  This study looks at rare infections in large blood vessels to better understand them and improve how they are treated.

  Recruiting Central Hospital, Nancy, France · Vandœuvre-lès-Nancy, Lorraine · NCT05660733

• How knee and hip joint replacements are doing over time

  This observational study follows adults who have knee or hip replacements to see how their outcomes look over time after the surgery.

  Recruiting University Hospital, Bonn · Bonn, North Rhine-Westphalia · NCT07799818

• Population pharmacokinetics of rifampicin in staphylococcal osteoarticular infections

  This study tests how rifampicin behaves in the body of adults with staphylococcal osteoarticular infections when given with levofloxacin or ciprofloxacin, to see how drug exposure relates to tolerance and outcomes.

  Recruiting Groupe Hospitalier Diaconesses Croix Saint-Simon · Paris, Paris · NCT07788404

• Reducing bacterial contamination during primary shoulder replacement

  This trial tests whether putting Prontosan antimicrobial gel on the dermal layer after the skin is cut can lower Cutibacterium acnes growth in men having primary shoulder replacement.

  Recruiting St. Louis University · St Louis, Missouri · NCT07406893

• Methylene blue dye to measure how much irrigation clears contamination during knee replacement procedures

  We will test whether putting methylene blue dye into the knee during replacement or DAIR procedures can show how much irrigation is needed to wash out contaminants.

  Recruiting Phase 1 University of Miami · Miami, Florida · NCT07324954

• PLG0206 irrigation to prevent repeat knee replacement infections after DAIR

  This will test if washing the knee with PLG0206 during a DAIR procedure can lower the chance that a prosthetic knee infection comes back in adults who had a knee replacement.

  Recruiting at 19 sites Phase 2/3 Peptilogics · Sarasota, Florida and 20 other locations · NCT07214311

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.