Rifampicin-containing regimens for Cutibacterium acnes prosthetic joint infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study examines treatment outcomes for prosthetic joint infections caused by Cutibacterium acnes. Participants must have a rifampicin-susceptible, monomicrobial C. acnes infection in a hip, knee, or shoulder prosthesis and be managed with a single-stage or two-stage revision. The interventions compare amoxicillin or moxifloxacin alone versus the same antibiotic regimen plus rifampicin, aiming to overcome biofilm-related challenges. Outcomes focus on treatment success in the context of biofilm-associated infection and antibiotic susceptibility. The study is conducted across multiple French sites with a lead sponsor at CHU Nice.

Why it matters

Who can join: the full rules

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);

Where it's running

• CH Annecy Genevois
  Annecy, France Recruiting
• CHU de BORDEAUX
  Bordeaux, France Recruiting
• Hôpital Ambroise Paré
  Boulogne, France Recruiting
• Hcl
  Lyon, France Recruiting
• CHU de MONTPELLIER
  Montpellier, France Recruiting
• CHU de Nantes
  Nantes, France Recruiting

Study contacts

• Study coordinator: Johan COURJON, MD
• Email: courjon.j@chu-nice.fr
• Phone: +33(0)492034562

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.