Comparing Rifabutin and Rifampicin for Treating Staphylococcal Prosthetic Joint Infection Using the DAIR Method

What this Trial Is About

Researchers are evaluating the use of rifabutin compared to rifampicin for treating staphylococcal prosthetic joint infections PJIs managed with a strategy called DAIR debridement, antibiotics, and implant retention. Rifampicin is a key antibiotic for these infections but has notable risks of drug interactions and liver problems. The study investigates whether rifabutin can be a safe and effective alternative with fewer side effects. This is a Phase 3, randomized, open-label trial aimed at demonstrating that rifabutin is not less effective than rifampicin for this treatment. Participants will be randomly assigned to one of two groups. One group will receive rifampicin combined with another antibiotic for 12 weeks according to current recommendations. The other group will receive rifabutin with a companion antibiotic, also for 12 weeks. Rifabutin is given as two 150 mg tablets once daily, while rifampicin dosing is based on weight 600 mg to 1200 mg daily. Both treatments are oral and part of combination antibiotic therapy during the DAIR procedure. During the study, researchers will monitor participants for treatment failure at one year, adverse events related to the antibiotics, adherence to the medication regimen, and completion of the 12-week treatment course. Quality of life and functional outcomes will be assessed using questionnaires over an average follow-up of 24 months. Safety monitoring includes checking for serious adverse events during and after treatment. Participants progress will be tracked through regular evaluations throughout the study period.

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR