Journal
TRIALS
Volume 24, Issue 1, Pages -Publisher
BMC
DOI: 10.1186/s13063-023-07141-2
Keywords
Orthopedic infections; Osteomyelitis; Surgical debridement; Antibiotic duration; Remission; Adverse events
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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.
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.
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