Status:
RECRUITING
Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
Lead Sponsor:
Tourcoing Hospital
Conditions:
Prosthetic Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 disorde...
Eligibility Criteria
Inclusion
- Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy)
- Infected with at least one of the following microorganisms:
- Staphylococcus aureus
- Coagulase-negative staphylococci
- 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.
- Age ≥ 18 years
- 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.
- Signed Inform consent
- Patient having the rights to French social insurance
- 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
- Suspicion of reduce absorption of oral treatment due to abdominal disorder Known or suspected malabsorption (imperfect absorption of food material by the small intestine)
- Polymicrobial infection due to other than staphylococcus species susceptible to rifampicin
- Known or suspected allergy to rifabutin and/or rifampicin
- Diagnosis of endocarditis associated to PJI
- Renal transplant or Chronic kidney disease with an eGFR of less than 30ml/min/1.73m²
- Other Solid Organ Transplant
- Liver cirrhosis, Child-Pugh score C
- Any other concomitant infection which required a prolonged course of intravenous antibiotic therapy
- Oestroprogestative-based contraception
- Oral anticoagulant drugs
- Other drug-drug interaction that contraindicated rifampicin or rifabutin
- Porphyria
- Unable to take oral treatment
- Receive empirical postoperative antibiotic treatment by rifampicin or rifabutin prior to randomization
- Pregnancy or lactating women
- Curator or guardianship or patient placed under judicial protection
- Participation in other interventional research during the study
Key Trial Info
Start Date :
November 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
436 Patients enrolled
Trial Details
Trial ID
NCT04672525
Start Date
November 8 2021
End Date
June 1 2027
Last Update
May 10 2022
Active Locations (30)
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1
CHU Amiens Picardie
Amiens, France
2
CHU Angers
Angers, France
3
CHU Besançon
Besançon, France
4
CH de Béthune
Béthune, France