Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

Last updated: May 9, 2022
Sponsor: Tourcoing Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04672525
RIPH_2019_01
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  1. Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapyinitiation and retention of prothesis (DAIR strategy)
  2. Infected with at least one of the following microorganisms:
  3. Staphylococcus aureus
  4. Coagulase-negative staphylococci
  5. Microorganisms susceptible to rifampicin and at least one other antibiotic suitablefor the treatment of PJI (e.g., penicillin, fluoroquinolone, (doxy/mino)cycline,oxazolidinone, cotrimoxazole, daptomycin, glycopeptide, macrolide, fusidic acid),regardless of sensitivity to methicillin.
  6. Age ≥ 18 years
  7. At least 2 days of appropriate (i.e., covering pathogen(s) identified in theintraoperative samples) empirical agents are needed. Pre-randomization antimicrobialtherapy 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.
  8. Signed Inform consent
  9. Patient having the rights to French social insurance
  10. For women of childbearing potential i.e. fertile, following menarche and untilbecoming post-menopausal unless permanently sterile and excludingoestroprogestative-based contraception, any effective contraceptive: vasectomy (formen), intrauterine device copper, feminine sterilization, condom, sexual abstinence isrequired. A postmenopausal state is defined as no menses for 12 months without analternative medical cause

Exclusion

Exclusion Criteria:

  1. Suspicion of reduce absorption of oral treatment due to abdominal disorder Known orsuspected malabsorption (imperfect absorption of food material by the small intestine)
  2. Polymicrobial infection due to other than staphylococcus species susceptible torifampicin
  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 intravenousantibiotic 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 priorto 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

Study Design

Total Participants: 436
Study Start date:
November 08, 2021
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • CHU Amiens Picardie

    Amiens,
    France

    Site Not Available

  • CHU Angers

    Angers,
    France

    Site Not Available

  • CHU Besançon

    Besançon,
    France

    Active - Recruiting

  • CHU Bordeaux

    Bordeaux,
    France

    Site Not Available

  • APHP Hôpital Ambroise Paré

    Boulogne-Billancourt,
    France

    Site Not Available

  • CHRU Brest

    Brest,
    France

    Active - Recruiting

  • CH de Béthune

    Béthune,
    France

    Site Not Available

  • CHU Caen

    Caen,
    France

    Active - Recruiting

  • CH Alpes Leman

    Contamine-sur-Arve,
    France

    Site Not Available

  • CHU Dijon Bourgogne

    Dijon,
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble,
    France

    Site Not Available

  • CHRU Lille

    Lille,
    France

    Active - Recruiting

  • GHICL Hôpital Saint Vincent de Paul

    Lille,
    France

    Site Not Available

  • CHU de Limoges

    Limoges,
    France

    Active - Recruiting

  • GHICL Hôpital Saint Philibert

    Lomme,
    France

    Site Not Available

  • Clinique de la Sauvegarde

    Lyon,
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon,
    France

    Site Not Available

  • APHM Hôpital Nord

    Marseille,
    France

    Site Not Available

  • CHU Nice

    Nice,
    France

    Site Not Available

  • CH Annecy Genevois

    Pringy,
    France

    Active - Recruiting

  • CH Cornouaille

    Quimper,
    France

    Site Not Available

  • CHU Reims

    Reims,
    France

    Site Not Available

  • CHU de Rennes

    Rennes,
    France

    Active - Recruiting

  • CHU Saint Etienne

    Saint-Priest-en-Jarez,
    France

    Site Not Available

  • CHRU Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Hôpital d'instruction des armées Sainte Anne

    Toulon,
    France

    Active - Recruiting

  • Clinique Joseph Ducuing

    Toulouse,
    France

    Site Not Available

  • Clinique Médipole Garonne

    Toulouse,
    France

    Site Not Available

  • CH Tourcoing

    Tourcoing,
    France

    Active - Recruiting

  • CHRU Tours

    Tours,
    France

    Active - Recruiting

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