Study protocol: short against long antibiotic therapy for infected orthopedic sites — the randomized-controlled SALATIO trials

Abstract

Background Few studies address the appropriate duration of post-surgical antibiotic therapy for orthopedic infections; with or without infected residual implants. We perform two similar randomized-clinical trials (RCT) to reduce the antibiotic use and associated adverse events. Methods Two unblinded RCTs in adult patients (non-inferiority with a margin of 10%, a power of 80%) with the primary outcomes “remission” and “microbiologically-identical recurrences” after a combined surgical and antibiotic therapy. The main secondary outcome is antibiotic-related adverse events. The RCTs allocate the participants between 3 vs. 6 weeks of post-surgical systemic antibiotic therapy for implant-free infections and between 6 vs. 12 weeks for residual implant-related infections. We need a total of 280 episodes (randomization schemes 1:1) with a minimal follow-up of 12 months. We perform two interim analyses starting approximately after 1 and 2 years. The study approximatively lasts 3 years. Discussion Both parallel RCTs will enable to prescribe less antibiotics for future orthopedic infections in adult patients. Trial registration ClinicalTrial.gov NCT05499481. Registered on 12 August 2022. Protocol version: 2 (19 May 2022)

The Impact of Antimicrobial Therapy Duration in the Treatment of Prosthetic Joint Infections Depending on Surgical Strategies: A Systematic Review and Meta-analysis

“…For these reasons, until this trend in favor of shorter antibiotic treatment duration is supported by new, high-quality studies (such as RCTs), we suggest to use a longer antibiotic treatment duration (eg, ≥12 weeks). In the future, we will hopefully have further high-quality RCTs stratified by type of surgical approach, kind of joints, causative pathogen, and antibiotic treatment options to obtain evidence to inform best practices for the antibiotic treatment of PJI [ 35 ].…”