Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Hip or knee Prosthetic joint infection treated by debridement, antibiotic therapyinitiation 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 suitablefor 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 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.
- Signed Inform consent
- Patient having the rights to French social insurance
- 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:
- Suspicion of reduce absorption of oral treatment due to abdominal disorder Known orsuspected malabsorption (imperfect absorption of food material by the small intestine)
- Polymicrobial infection due to other than staphylococcus species susceptible torifampicin
- 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 intravenousantibiotic 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 priorto randomization
- Pregnancy or lactating women
- Curator or guardianship or patient placed under judicial protection
- Participation in other interventional research during the study
Study Design
Connect with a study center
CHU Amiens Picardie
Amiens,
FranceSite Not Available
CHU Angers
Angers,
FranceSite Not Available
CHU Besançon
Besançon,
FranceActive - Recruiting
CHU Bordeaux
Bordeaux,
FranceSite Not Available
APHP Hôpital Ambroise Paré
Boulogne-Billancourt,
FranceSite Not Available
CHRU Brest
Brest,
FranceActive - Recruiting
CH de Béthune
Béthune,
FranceSite Not Available
CHU Caen
Caen,
FranceActive - Recruiting
CH Alpes Leman
Contamine-sur-Arve,
FranceSite Not Available
CHU Dijon Bourgogne
Dijon,
FranceSite Not Available
CHU Grenoble Alpes
Grenoble,
FranceSite Not Available
CHRU Lille
Lille,
FranceActive - Recruiting
GHICL Hôpital Saint Vincent de Paul
Lille,
FranceSite Not Available
CHU de Limoges
Limoges,
FranceActive - Recruiting
GHICL Hôpital Saint Philibert
Lomme,
FranceSite Not Available
Clinique de la Sauvegarde
Lyon,
FranceSite Not Available
Hospices Civils de Lyon
Lyon,
FranceSite Not Available
APHM Hôpital Nord
Marseille,
FranceSite Not Available
CHU Nice
Nice,
FranceSite Not Available
CH Annecy Genevois
Pringy,
FranceActive - Recruiting
CH Cornouaille
Quimper,
FranceSite Not Available
CHU Reims
Reims,
FranceSite Not Available
CHU de Rennes
Rennes,
FranceActive - Recruiting
CHU Saint Etienne
Saint-Priest-en-Jarez,
FranceSite Not Available
CHRU Strasbourg
Strasbourg,
FranceSite Not Available
Hôpital d'instruction des armées Sainte Anne
Toulon,
FranceActive - Recruiting
Clinique Joseph Ducuing
Toulouse,
FranceSite Not Available
Clinique Médipole Garonne
Toulouse,
FranceSite Not Available
CH Tourcoing
Tourcoing,
FranceActive - Recruiting
CHRU Tours
Tours,
FranceActive - Recruiting
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