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Compares treatment options for Prosthetic Infection
Official title Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR
ClinicalTrials.gov ID: NCT04672525
What this study is testing
What is Rifabutin?
Rifabutin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for prosthetic infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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)
- 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...
You likely can't join if
- Suspicion of reduce absorption of oral treatment due to abdominal disorder Known or suspected malabsorption (imperfect absorption of food material by...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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 treatment research during the study
The study team makes the final eligibility decision.
Where it's taking place
- Amiens, France
- Angers, France
- Besançon, France
- Béthune, France
- Bordeaux, France
- Boulogne-Billancourt, France
- Brest, France
- Caen, France
- Contamine-sur-Arve, France
- Dijon, France
- Grenoble, France
- Lille, France
- Limoges, France
- Lomme, France
- Lyon, France
- Marseille, France
- Nice, France
- Pringy, France
- Quimper, France
- Reims, France
+ 7 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amiens, France; Angers, France; Besançon, France; Béthune, France; Bordeaux, France; Boulogne-Billancourt, France and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.