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).
Keywords: Adverse events; Antibiotic duration; Orthopedic infections; Osteomyelitis; Remission; Surgical debridement.
© 2023. The Author(s).