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

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.

Automated summary

In order to reduce antibiotic use and associated adverse events, we conducted two similar randomized controlled trials to explore the appropriate duration of post-surgical antibiotic therapy for orthopedic infections. The primary outcomes were remission and microbiologically-identical recurrences, while the main secondary outcome was antibiotic-related adverse events.