Rifampicin Combination Therapy Versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection

What this Trial Is About

Researchers are evaluating treatments for staphylococcal prosthetic joint infections in this Dutch multicenter clinical trial. The study compares two oral antibiotic approaches given after initial surgery to remove infection: rifampicin combined with levofloxacin versus clindamycin alone. The goal is to determine whether the combination therapy is at least as effective as monotherapy by checking treatment success one year after finishing antibiotics. This trial uses a randomized open-label design and follows patients for a total of 15 months from their initial surgery. Participants receive either rifampicin 450 mg twice daily plus levofloxacin 500 mg twice daily, or clindamycin 600 mg three times daily during a 12-week oral antibiotic treatment phase. All patients have hip or knee prosthetic joint infections caused by Staphylococcus species and are treated with a debridement, antibiotics, and implant retention (DAIR) surgical strategy. The study excludes patients with contraindications to the antibiotics, complicated bloodstream infections, or other specific medical conditions. During the study, participants will be monitored through quality of life questionnaires given at baseline, 6 weeks, and 3 months after surgery. Researchers will track adverse events, antibiotic switches, development of antibiotic resistance, and any recurrence of infection or need for additional surgery. The primary outcome is treatment success measured 15 months after surgery, defined by no infection-related surgery, no new antibiotic treatment, no ongoing antibiotics, and survival. The total follow-up lasts approximately 15 months after the initial surgical intervention.

Rifampicin Combination Therapy Versus Monotherapy for Staphylococcal Prosthetic Joint Infection