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

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).

SUBMITTER: Uckay I 

PROVIDER: S-EPMC9938993 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature