The results of a multicenter randomized controlled trial indicate that a short course of systemic antibiotics is noninferior to a long course in patients who’ve undergone orthopedic surgery, researchers reported last week in the New England Journal of Medicine.
Conducted at 25 sites in the United Kingdom, Austria, Germany, Portugal, and Spain, the SOLARIO (Short or Long Antibiotic Regimens in Orthopaedics) trial randomly assigned 500 patients who’d undergone surgery for a confirmed orthopedic infection to receive postoperative antibiotic therapy for a short duration (seven days or less) or a long duration (four or more weeks). Local antibiotics were delivered by a device that was implanted during surgery. The primary outcome was definite treatment failure by 12 months, with a noninferiority margin of 10 percentage points.
Postoperative systemic antibiotic treatment for orthopedic infection typically lasts at least four weeks.
“Orthopedic infection is usually managed with surgery and prolonged systemic antibiotic therapy,” a team led by investigators from Oxford University Hospitals wrote. “Whether local antibiotics delivered by a product implanted at the infection site during surgery can reduce the duration of systemic antibiotic therapy is unclear.”
Less treatment failure, fewer side effects
Definite treatment failure occurred in 14.1% of patients in the long-duration group and 11.1% in the short-duration group, for a risk difference of –3.0 percentage points, which met the prespecified noninferiority margin. Results of sensitivity analyses were consistent with the primary analysis.
Potential side effects of antibiotic therapy, a secondary outcome, occurred in 45.2% of patients in the long-therapy group and 17.2% of patients in the short-duration group (risk difference, –28.0 percentage points.)
“The anticipated advantages of short-duration therapy, which include fewer symptoms associated with treatment and shorter durations of hospital stay without an increased risk of death or serious adverse events, were seen in the current trial,” the authors wrote.