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

Trials, 2023 · DOI: https://doi.org/10.1186/s13063-023-07141-2 · Published: February 7, 2023

Simple Explanation

This study aims to determine the appropriate duration of antibiotic treatment after surgery for orthopedic infections. Two similar randomized controlled trials (RCTs) will compare shorter versus longer durations of antibiotic therapy to see if shorter durations are as effective. The study will also investigate whether shorter antibiotic durations can reduce antibiotic use and related side effects.

Study Duration

3 years

Participants

280 episodes (adult patients)

Evidence Level

Level 1: Randomized-clinical trials (RCT)

Key Findings

1
The study will evaluate if 6 weeks of antibiotics is non-inferior to 12 weeks for infections with retained implants.
2
For infections with complete implant removal, the study investigates if 3 weeks of antibiotics is non-inferior to 6 weeks.
3
The primary outcomes are remission at 1 year and the proportion of recurrent infections due to the same pathogens.

Research Summary

The SALATIO trials aim to determine if shorter durations of antibiotic therapy are non-inferior to longer durations for orthopedic infections after surgical debridement. Two RCTs will be conducted, one for infections with retained implants (6 vs. 12 weeks) and one for infections with complete implant removal (3 vs. 6 weeks). The study will assess remission rates, recurrence rates, adverse events, and length of hospital stay.

Practical Implications

Reduced Antibiotic Use

Shorter antibiotic courses can potentially decrease the overall antibiotic consumption, contributing to antibiotic stewardship.

Reduced Adverse Events

Shorter antibiotic durations may reduce the risk of antibiotic-related adverse events in patients with orthopedic infections.

Optimized Treatment Strategies

The findings can help refine the guidelines for post-surgical antibiotic therapy in orthopedic infections, leading to more efficient treatment protocols.

Study Limitations

1
The study excludes soft tissue infections and native joint septic arthritis.
2
The study does not investigate the reduction of systemic antibiotic use with local antibiotic release.
3
The trials require a professional debridement which may introduce a 'hospital bias'.

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