Short or Long Antibiotic Regimens in Orthopedics

BACKGROUND: Orthopedic 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. METHODS: In 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. RESULTS: A 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). CONCLUSIONS: Among 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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Publication Details

Journal
New England Journal of Medicine
Published
2026-09-16
DOI
https://doi.org/10.1056/nejmoa2506756
Primary Topic
Orthopedic Infections and Treatments
Type
article
Field-Weighted Citation Impact
0.00

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article

Short or Long Antibiotic Regimens in Orthopedics

Simon Warren, Antony Palmer, B. Ollivere, Abtin Alvand et al.
New England Journal of Medicine
Orthopedic Infections and Treatments
article

Short or Long Antibiotic Regimens in Orthopedics

Simon Warren, Antony Palmer, B. Ollivere, Abtin Alvand, Daniel Pérez‐Prieto, Alexis D. Iliadis, Steve A. Jones, Irene Katharina Sigmund, Matthew Cichero, Maria Dudareva, O. Martin Williams, Anand Pillai, Andre D. Carvalho, Matthew Scarborough, Claire L. Scarborough, Bernadette Young, Werner Vach, Michelle Kümin, Adrian Kendal, Sunil Sharma, Bridget L. Atkins, Andrew Bing, Martin McNally, Henry Wynn Jones, Neil Jenkins, Harriet Hughes, Simon Ellis, John Williams, Amirul Islam, Aaron Ng, Adrian Taylor, Neal Jacobs, David A. Stubbs, Reinhard Windhager, Jamie Ferguson, Michael J. Riste, Andreas Leithner, Alex J. Ramsden, Ricardo Sousa, Ben Kendrick, Jonathan Folb, Con L. Loizou, Volker Alt
article en

Abstract

BACKGROUND: Orthopedic 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. METHODS: In 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. RESULTS: A 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). CONCLUSIONS: Among 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.).

New England Journal of Medicine
Cardiff and Vale University Health Board (GB), University Hospitals Birmingham NHS Foundation Trust (GB), Medical University of Graz (AT), Barts Health NHS Trust (GB), University Hospitals Bristol NHS Foundation Trust (GB), University Hospital of Wales (GB), Northumbria Healthcare NHS Foundation Trust (GB), Nuffield Orthopaedic Centre (GB), Wrightington, Wigan and Leigh NHS Foundation Trust (GB), Robert Jones and Agnes Hunt Orthopaedic Hospital (GB), Royal Liverpool and Broadgreen University Hospital NHS Trust (GB), South Tees Hospitals NHS Foundation Trust (GB), University Hospital Regensburg (DE), University of Oxford (GB), Manchester University NHS Foundation Trust (GB), Royal National Orthopaedic Hospital NHS Trust (GB), Hospital de Santo António (PT), Great Western Hospitals NHS Foundation Trust (GB), Nottingham Biomedical Research Centre (GB), University Hospitals Sussex NHS Foundation Trust (GB), Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Trust (GB), Hospital del Mar Research Institute (ES), Mid Yorkshire Hospitals NHS Trust (GB), University College London (GB), Medical University of Vienna (AT), Salisbury NHS Foundation Trust (GB)
National Institute for Health and Care Research, British Medical Association
Zero hunger
Openalex Percentile: Top 8%
Orthopedic Infections and Treatments
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