TOPLINE
In patients who had a local antibiotic carrier implanted during surgery for orthopedic infections, a short course (≤ 7 days) of postoperative systemic antibiotics was noninferior to a long course (≥ 4 weeks) in terms of the rate of definite treatment failure at 12 months.
METHODOLOGY
- Researchers conducted a randomized, noninferiority trial to evaluate whether the use of local antibiotic therapy could enable a substantially shorter course of systemic antibiotics in patients with bone and joint infections without compromising safety.
- The study included 500 adults aged 18 years or older who underwent definitive surgery for a confirmed orthopedic infection with implantation of a licensed local antibiotic carrier. They were randomly assigned to receive postoperative systemic antibiotics for either a short duration (≤ 7 days) or long duration (≥ 4 weeks); of these, 475 patients were included in the primary analysis.
- The primary outcome was definite treatment failure occurring within 12 months after surgery, defined as the presence of a sinus tract or pus at the surgical site, an infection confirmed at reoperation, elevated levels of synovial fluid biomarkers, or death from a surgical-site infection. The noninferiority margin was prespecified at 10 percentage points.
- The secondary outcomes included overall survival, potential side effects of antibiotic therapy, and serious adverse events. The median duration of systemic therapy was 6 days in the short-duration group and 42 days in the long-duration group.
TAKEAWAY
- In the eligible population, definite treatment failure within 12 months occurred in 11.1% (26/234) of patients in the short-duration group and 14.1% (34/241) of patients in the long-duration group, representing a risk difference of -3.0 percentage points, which was well within the prespecified 10-percentage-point noninferiority margin.
- Results were consistent in sensitivity analyses in the included population (n = 497) and the per-protocol population (n = 457), with risk differences of −2.4 and −2.7 percentage points, respectively.
- At week 6 after surgery, treatment-related symptoms were less common in the short-duration group than in the long-duration group (17.2% vs 45.2%; risk difference, -28.0 percentage points).
- Overall survival at 12 months was greater in the short-duration group than in the long-duration group (97.9% vs 96.3%; hazard ratio for death, 1.76). The short-duration group also had fewer serious adverse events (40 patients vs 48 patients) and deaths (five patients vs nine patients) than the long-duration group.
IN PRACTICE
"In the current trial, a short course (≤ 7 days) of systemic antibiotics was noninferior to a long course (≥ 4 weeks) with regard to definite treatment failure at 12 months in patients who had undergone surgical management of bone and joint infection that included local antibiotics," the authors of the study wrote.
SOURCE
The study was led by Martin McNally, MD, F.R.C.S.Ed., F.R.C.S.(Orth.), Bone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals in Oxford, England. It was published online on September 16, 2026, in New England Journal of Medicine.
LIMITATIONS
The trial's open-label design reflected the impracticality of matching placebos to varied antibiotic regimens. Patients undergoing debridement, antibiotics, and implant retention procedure were excluded. Potential selection bias could have existed as clinicians with conservative approaches may not have recruited high-risk patients.
DISCLOSURES
The study was supported by the European Bone and Joint Infection Society, the National Institute for Health Research, and a Kathleen Harper grant from the British Medical Association. Several authors reported receiving grants, consulting fees, or research support from and having other ties with various sources. Full author disclosures are reported in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
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