Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections (RIFACute)
Infections Joint Prosthetic
About this trial
This is an interventional treatment trial for Infections Joint Prosthetic
Eligibility Criteria
Inclusion Criteria: Age: > or =18 years old; Monomicrobial, rifampicin susceptible Cutibacterium acnes late total knee arthroplasty (TKA) or hip arthroplasty (total, THA or hemiarthroplasty, HH) or shoulder arthroplasty (total, TSA or hemiarthroplasty, SH) infection treated surgically with single-stage or two-stage revision; Isolation of C. acnes on two distinct per-operative samples collected during the single-stage or the two-stage revision Based on the antimicrobial susceptibility test of the C. acnes and the medical history of the patient, the PJI can be treated with amoxicillin or moxifloxacin; Women considered of childbearing potential (WOCBP) requires use of a highly effective contraceptive measure as intrauterine device (IUD), intrauterine hormone-releasing system (IUS), documented bilateral tubal occlusion, documented vasectomised partner, sexual abstinence. Contraception should be maintained during treatment and until the end of relevant systemic exposure. Exclusion Criteria: Contraindication to Rifampicin (included ongoing treatment contraindicated with rifampicin) Contraindication to Amoxicillin AND moxifloxacin (included ongoing treatment contraindicated with these medicines) Empirical antibiotic treatment not administered during the 24 hours following revision surgery; Inactive empirical antibiotic treatment following surgery according to the AST of the bacteria; disease-modifying treatment incompatible with the inducer effect of rifampicin Liver cirrhosis; Pregnancy: a pregnancy blood test will be performed on all women of childbearing age. The results will be sent to the patient by the doctor of their choice; Porphyria; Renal insufficiency with GFR < 30ml/min/1.73 m2 (CKD-EPI);
Sites / Locations
- CH Annecy Genevois
- CHU de BORDEAUX
- HCL
- AP-HM
- CHU de MONTPELLIER
- CHU de Nantes
- CHU de NICE
- Dianonesses croix saint simon
- CHU de Rennes
- CHU Toulouse
- Ch Tourcoing
- CHRU Tours
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Antibiotic treatment backbone alone
Antibiotic treatment backbone + rifampicin
Amoxicillin or moxifloxacin to the investigator's discretion
Amoxicillin or moxifloxacin to the investigator's discretion + RIMACTAN