ArticleThe New England journal of medicine2026
Short or Long Antibiotic Regimens in Orthopedics.
Article in The New England journal of medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03806166 (Short or Long Antibiotic Regimes in Orthopaedics), which is not on this map. Not yet cited in PubMed.
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Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial
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43 authors.
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Abstract
backgroundOrthopedic infection is usually managed with surgery and prolonged systemic antibiotic therapy. Whether local antibiotics delivered by a product implanted at the infection site during surgery can reduce the duration of systemic antibiotic therapy is unclear.
methodsIn a multicenter, open-label, noninferiority trial, we randomly assigned, in a 1:1 ratio, adults who had undergone surgery for orthopedic infection and implantation of a local-antibiotic carrier to receive postoperative systemic antibiotic therapy for a long (≥4 weeks) or short (≤7 days) duration. The primary outcome was definite treatment failure by 12 months, assessed according to protocol-defined criteria by a clinical end-point committee whose members were unaware of the trial-group assignments. The noninferiority margin was 10 percentage points.
resultsA total of 500 patients underwent randomization, of whom 475 were assessed in the primary analysis. Definite treatment failure occurred in 34 of 241 patients (14.1%) in the long-duration group and in 26 of 234 patients (11.1%) in the short-duration group (risk difference [negative values favor the short duration], -3.0 percentage points; 95% confidence interval [CI], -9.0 to 3.0), which met the prespecified noninferiority margin. In sensitivity analyses in the included population (497 patients) and the per-protocol population (457 patients), results were consistent with those of the primary analysis (risk difference, -2.4 percentage points [95% CI, -8.2 to 3.5] and -2.7 percentage points [95% CI, -8.8 to 3.4], respectively). By week 6 after surgery, symptoms potentially related to treatment had occurred in 45.2% of the patients in the long-duration group and in 17.2% of those in the short-duration group (risk difference, -28.0 percentage points; 95% CI, -36.4 to -19.6).
conclusionsAmong patients who had undergone orthopedic surgery and received local antibiotics, a short course of systemic antibiotics was noninferior to a long course with respect to definite treatment failure by 12 months. (Funded by the European Bone and Joint Infection Society and others; SOLARIO ClinicalTrials.gov number, NCT03806166.).
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