Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

Recruiting now · Phase 3

Conditions studied: Prosthetic Infection

In brief

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.

Key facts

Study ID

NCT04672525

Run by

Tourcoing Hospital

People needed

436

Starts

2021-11-08

Expected to finish

2027-06-01

Last updated by the study team

2022-05-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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, (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

You may not qualify if…

• 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

Where it is running

• CHRU Brest — Brest, France (enrolling)
• CHU Caen — Caen, France (enrolling)
• CHU de Rennes — Rennes, France (enrolling)
• CHRU Lille — Lille, France (enrolling)
• CHU Besançon — Besançon, France (enrolling)
• Hôpital d'instruction des armées Sainte Anne — Toulon, France (enrolling)
• CHU de Limoges — Limoges, France (enrolling)
• CH Annecy Genevois — Pringy, France (enrolling)
• CH Tourcoing — Tourcoing, France (enrolling)
• CHRU Tours — Tours, France (enrolling)
• CHU Amiens Picardie — Amiens, France
• Hospices Civils de Lyon — Lyon, France
• APHM Hôpital Nord — Marseille, France
• CHU Nice — Nice, France
• CH Cornouaille — Quimper, France
• CHU Reims — Reims, France
• CHU Saint Etienne — Saint-Priest-en-Jarez, France
• CHRU Strasbourg — Strasbourg, France
• Clinique Joseph Ducuing — Toulouse, France
• Clinique Médipole Garonne — Toulouse, France
• Clinique de la Sauvegarde — Lyon, France
• CHU Angers — Angers, France
• CH de Béthune — Béthune, France
• CHU Bordeaux — Bordeaux, France
• APHP Hôpital Ambroise Paré — Boulogne-Billancourt, France

Full record on ClinicalTrials.gov

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