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RIFAMAB : Rifabutin versus rifampicin, staphylococcal prosthetic joint infection, multicenter randomized, open-label, non-inferiority trial
EU CTIS ID: 2024-519894-20-01
What this study is testing
To demonstrate that in DAIR strategy for prosthetic joint infection due to staphylococci (S. aureus and CoNS) susceptible or resistant to methicillin, oral rifabutin is non-inferior to oral rifampicin.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy)
- Microbiologically documented infection corresponds to the isolation of staphylococcus aureus or coagulase-negative Staphylococcus aureus from reliable samples: intraoperatively (≥ 3 during synovectomywashing), joint puncture or blood culture; the microorganism(s) will be considered pathogenic if identified in ≥ 2 reliable samples.
- 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.
- Signed Inform consent
You likely can't join if
- Known or suspected malabsorption (imperfect absorption of food material by the small intestine)
- Ongoing treatment that contraindicates the use of rifampicin or rifabutine
- Porphyria
- Unable to take oral treatment
- Receive empirical postoperative antibiotic treatment by rifampicin or rifabutin prior to randomization
- Pregnancy or lactating women
See the full eligibility criteria
- Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapy initiation and retention of prothesis (DAIR strategy)
- Microbiologically documented infection corresponds to the isolation of staphylococcus aureus or coagulase-negative Staphylococcus aureus from reliable samples: intraoperatively (≥ 3 during synovectomywashing), joint puncture or blood culture; the microorganism(s) will be considered pathogenic if identified in ≥ 2 reliable samples.
- 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.
- 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.
- Known or suspected malabsorption (imperfect absorption of food material by the small intestine)
- Ongoing treatment that contraindicates the use of rifampicin or rifabutine
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.