Impact of Rifampicin in Treatment Outcome of Cutibacterium Acnes Prosthetic Joint Infections

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NICE · Jun 5, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the impact of a specific antibiotic called rifampicin on treating infections caused by Cutibacterium acnes in patients who have had joint replacement surgeries, such as hip or knee replacements. Cutibacterium acnes is a type of bacteria that can cause infections in prosthetic joints, and these infections can be difficult to treat because the bacteria form a protective layer called biofilm. By using rifampicin, researchers hope to improve treatment outcomes for patients with these infections.

To be eligible for this trial, participants must be at least 18 years old and have a confirmed infection caused by Cutibacterium acnes after having surgery on their knee, hip, or shoulder. The trial is looking for patients whose infection can be treated with rifampicin, along with other antibiotics like amoxicillin or moxifloxacin. Participants will need to meet certain health criteria and may be required to use effective birth control during the study. The trial is not yet recruiting, so interested individuals should stay informed for updates.

Gender

ALL

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);