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Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomised controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy

Authors
  • Dudareva, Maria1
  • Kümin, Michelle2
  • Vach, Werner3
  • Kaier, Klaus4
  • Ferguson, Jamie1
  • McNally, Martin1
  • Scarborough, Matthew1
  • 1 Oxford University Hospitals, Oxford, UK , Oxford (United Kingdom)
  • 2 University of Oxford, Oxford, UK , Oxford (United Kingdom)
  • 3 Universitätsspital Basel, Basel, Switzerland , Basel (Switzerland)
  • 4 Institute of Medical Biometry and Medical Informatics, Universitätsklinikums Freiburg, Freiburg, Germany , Freiburg (Germany)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Dec 09, 2019
Volume
20
Issue
1
Identifiers
DOI: 10.1186/s13063-019-3832-3
Source
Springer Nature
Keywords
License
Green

Abstract

BackgroundOrthopaedic infections, such as osteomyelitis, diabetic foot infection and prosthetic joint infection, are most commonly treated by a combination of surgical debridement and a prolonged course of systemic antibiotics, usually for at least 4–6 weeks. Use of local antibiotics, implanted directly into the site of infection at the time of surgery, may improve antibiotic delivery and allow us to shorten the duration of systemic antibiotic therapy, thereby limiting the frequency of side effects, cost and selection pressure for antimicrobial resistance.MethodsSOLARIO is a multicentre open-label randomised controlled non-inferiority trial comparing short and long systemic antibiotic therapy alongside local antibiotic therapy. Adult patients with orthopaedic infection, who have given informed consent, will be eligible to participate in the study provided that no micro-organisms identified from deep tissue samples are resistant to locally implanted antibiotics. Participants will be randomised in a 1:1 ratio to receive either a short course (≤ 7 days) or currently recommended long course (≥ 4 weeks) of systemic antibiotics. The primary outcome will be treatment failure by 12 months after surgery, as ascertained by an independent Endpoint Committee blinded to treatment allocation. An absolute non-inferiority margin of 10% will be used for both per-protocol and intention-to-treat populations. Secondary outcomes will include probable and definite treatment failure, serious adverse events, treatment side effects, quality of life scores and cost analysis.DiscussionThis study aims to assess a treatment strategy that may enable the reduction of systemic antibiotic use for patients with orthopaedic infection. If this strategy is non-inferior, this will be to the advantage of patients and contribute to antimicrobial stewardship.Trial registrationClinicaltrials.gov, NCT03806166. Registered on 11 November 2019.

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