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

Autor: Ilker Uçkay, Stephan Wirth, Björn Zörner, Sandro Fucentese, Karl Wieser, Andreas Schweizer, Daniel Müller, Patrick Zingg, Mazda Farshad
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Trials, Vol 24, Iss 1, Pp 1-12 (2023)
Druh dokumentu: article
ISSN: 1745-6215
DOI: 10.1186/s13063-023-07141-2
Popis: 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)
Databáze: Directory of Open Access Journals
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