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Recruiting Phase 3

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

NCT04672525 · tracked via the Priya Life Science France tracker
Sponsor
Tourcoing Hospital
Phase
Phase 3
Started
2021-11-08
Last updated
2022-05-10

Condition(s) studied

Prosthetic Infection

Investigational drug(s) / intervention(s)

Rifabutin →Rifampicin →

Rifabutin: 2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment

Rifampicin: 10 mg/kg per day (range 600 mg to 1,200 mg) rifampicin tablet in 1 daily dose for 12 weeks with a companion treatment

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Treatment failure — At one year
    Treatment failure defined as one of following events: * The need for any further surgical procedure - i.e. implants removal, implants exchange or amputation; * And/or PJI related death; * And/or use of suppressive antibiotic therapy that was not planned before randomization

Trial sites (30)

FacilityCityRegionStatus
CHU Amiens Picardie Amiens France Not Yet Recruiting
CHU Angers Angers France Not Yet Recruiting
CHU Besançon Besançon France Recruiting
CH de Béthune Béthune France Not Yet Recruiting
CHU Bordeaux Bordeaux France Not Yet Recruiting
APHP Hôpital Ambroise Paré Boulogne-Billancourt France Not Yet Recruiting
CHRU Brest Brest France Recruiting
CHU Caen Caen France Recruiting
CH Alpes Leman Contamine-sur-Arve France Not Yet Recruiting
CHU Dijon Bourgogne Dijon France Not Yet Recruiting
CHU Grenoble Alpes Grenoble France Not Yet Recruiting
CHRU Lille Lille France Recruiting
GHICL Hôpital Saint Vincent de Paul Lille France Not Yet Recruiting
CHU de Limoges Limoges France Recruiting
GHICL Hôpital Saint Philibert Lomme France Not Yet Recruiting
Clinique de la Sauvegarde Lyon France Not Yet Recruiting
Hospices Civils de Lyon Lyon France Not Yet Recruiting
APHM Hôpital Nord Marseille France Not Yet Recruiting
CHU Nice Nice France Not Yet Recruiting
CH Annecy Genevois Pringy France Recruiting
CH Cornouaille Quimper France Not Yet Recruiting
CHU Reims Reims France Not Yet Recruiting
CHU de Rennes Rennes France Recruiting
CHU Saint Etienne Saint-Priest-en-Jarez France Not Yet Recruiting
CHRU Strasbourg Strasbourg France Not Yet Recruiting
Hôpital d'instruction des armées Sainte Anne Toulon France Recruiting
Clinique Joseph Ducuing Toulouse France Not Yet Recruiting
Clinique Médipole Garonne Toulouse France Not Yet Recruiting
CH Tourcoing Tourcoing France Recruiting
CHRU Tours Tours France Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04672525 on ClinicalTrials.gov ↗ ← All trials in France