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.
Highlights
Orthopaedic 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
Primary objective The primary objective of the present study is to determine whether treatment of orthopaedic infection with local antibiotics combined with ≤ 7 days of systemic therapy is non-inferior to treatment with local antibiotics combined with ≥ 4 weeks of systemic therapy, as assessed by treatment failure rate at one year
Secondary objectives Secondary objectives of the present study are to compare the following secondary endpoints according to treatment allocation: 1) probable treatment failure and possible treatment failure; 2) serious adverse events (SAEs), including death; 3) antibiotic side effects related to the treatment of orthopaedic infection; 4) resource allocation using (a) length of inpatient hospital stay, (b) frequency of outpatient visits, (c) antibiotic prescribing costs
Summary
Orthopaedic 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. Around one in six patients treated with antibiotics for chronic osteomyelitis experience adverse drug reactions [2, 3] and bacterial resistance to broad-spectrum last resort antibiotics, such as carbapenems, has risen substantially in the UK over the past 10 years, driven by evolution under selection pressure from systemic antibiotic use [4, 5]. At least 4–6 weeks of postoperative oral or intravenous antibiotics are currently recommended for orthopaedic infections, which is much longer than for common soft-tissue bacterial infections [10,11,12,13]
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