biostudies-literatureUckay IBalgrist117https://www.ebi.ac.uk/biostudies/studies/S-EPMC9938993biostudies-literatureUnknown24(1)<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>Both parallel RCTs will enable to prescribe less antibiotics for future orthopedic infections in adult patients.<h4>Trial registration</h4>ClinicalTrial.gov NCT05499481. Registered on 12 August 2022.<h4>Protocol version</h4>2 (19 May 2022).TrialsStudy protocol: short against long antibiotic therapy for infected orthopedic sites - the randomized-controlled SALATIO trials.PMC9938993W956Wirth SZorner BZingg PFucentese SMuller DWieser KSchweizer AUckay IFarshad MfalseStudy protocol: short against long antibiotic therapy for infected orthopedic sites - the randomized-controlled SALATIO trials.<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Discussion</h4>Both parallel RCTs will enable to prescribe less antibiotics for future orthopedic infections in adult patients.<h4>Trial registration</h4>ClinicalTrial.gov NCT05499481. Registered on 12 August 2022.<h4>Protocol version</h4>2 (19 May 2022).2023-01-01T00:00:00Z2023 Feb2026-07-14T16:57:20.837Z2025-02-18T22:56:21.049ZS-EPMC99389933680383710.1186/s13063-023-07141-2