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Short Against Long Antibiotic Therapy for Infected Orthopedic Sites — SALATIO  

Antibiotic Side Effect Clinical Trial

Official title:
Short Against Long Antibiotic Therapy for Infected Orthopedic Sites

Clinical Trial Summary

The investigators will perform two concomitant RCTs, depending on the presence of infected osteosynthesis material at enrolment: - SALATIO 1. Infected implant not removed (or new material inserted): Randomization 6 vs. 12 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy. - SALATIO 2. Infected implant without residual material (definitive removal or within the interval of a two-stage exchange): Randomization 3 vs. 6 weeks (+/- 5 days) of total antibiotic therapy counted since the first debridement for infection. Early switch to oral targeted therapy.

Clinical Trial Description

The optimal duration of postoperative, systemic antibiotic therapy for implant-related orthopedic infections, with or without implant removal, is unknown. Retrospective studies suggest that a maximum duration of 6 weeks is not inferior to longer administrations; even if the infected implants are kept in place or during a one-stage exchange. Prospective-randomized trials (RCT) suggest that even shorter durations, such 3 or 4 weeks, are possible, when the implant is removed. Likewise, in prospective studies, 6 or 8 weeks of systemic antibiotics are not inferior to the current 12 weeks during DAIR (debridement, antibiotic and implant retention), or during the one-stage exchange; except for one single RCT suggesting a better outcome for 12 weeks in the substrata of arthroplasty infections undergoing the DAIR procedure. However, these RCTs concern selected branches of orthopedic surgery; especially prosthetic joint infections. The investigators intend to expand these evaluations to all fields of orthopedic and hand surgery. The only exceptions would be spine surgery, for which a multicenter, separate RCT is already under way (SASI-trials). The second exception would be the treatment of implant-free diabetic foot infections, for which two RCTs are underway. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05499481
Study type Interventional
Source Balgrist University Hospital
Contact Ilker Uçkay, Professor
Phone ++41 44 386 37 05
Email ilker.uckay@balgrist.ch
Status Recruiting
Phase Phase 3
Start date September 15, 2022
Completion date September 30, 2025
View Details
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