Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO)
Research type
Research Study
Full title
Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial
IRAS ID
244229
Contact name
Matthew Scarborough
Contact email
Sponsor organisation
Oxford University Hospitals NHS Trust- R&D Department
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
Research question:
If adults with bone or joint infection have local antibiotic therapy, can they do without prolonged treatment with antibiotics by mouth (oral) or injection?Why?
Adults with bone or joint infections are usually given long courses of oral antibiotics or into a vein (intravenous) following surgery.
It is also safe to give antibiotics directly into the bone or joint at the time of surgery: this is called local antibiotic therapy. We wish to investigate whether using local antibiotic therapy would allow shorter courses of oral or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost.What?
This study compares short against long courses of oral or intravenous antibiotics for adults who have been given appropriate local antibiotic therapy to treat bone or joint infection.
Patients who can take part will be randomly divided into two groups within 7 days of surgery. One group will stop oral or intravenous antibiotics, while the other group will continue for 4 weeks or more (standard treatment).Where:
The study will take place in 9 hospitals: 6 NHS hospitals and 3 in mainland Europe.Who:
Adults with bone and joint infections who have already had surgery and local antibiotic therapy. Patients will not take part if they need intravenous antibiotics for another reason, or if their infection is caused by bacteria resistant to the antibiotic(s) used in their local antibiotic therapy.How?
Main measurement: how many patients' infections return within 12 months after surgery. This will be decided by a group of doctors who do not know what treatment the patient received.Other important measurements: serious adverse events; side-effects; quality of life; cost of treatment.
Patients will be asked questions at their usual clinic visits, and will be given a questionnaire at the start of treatment and 1 year later.
Lay summary of study results: The SOLARIO trial was a randomised, open label, multi-centre clinical trial led by Oxford University Hospitals NHS Trust. It was designed to compare SHORT and LONG antibiotic regimes when treating patients undergoing surgical intervention for bone or joint infection.
Participants randomised to the SHORT arm of the trial had ≤7 days of systemic antibiotics. Participants randomised to the LONG arm of the trial continued with standard treatment (4 weeks systemic antibiotics). All participants had local antibiotics in a suitable carrier applied directly to the site of infection at the time of surgery. Throughout the trial, an independent data safety monitoring board assessed the safety of the trial’s interventions and monitored the trial’s overall conduct in order to safeguard the interests of the trial participants and to protect the trial’s validity and credibility.
The trial was opened in 35 sites across England, Portugal, Spain, Austria and Germany. The first patient was recruited on 21st February 2019. Recruitment was affected by the COVID-19 pandemic and the trial was delayed. Only 25 out of the 35 sites were able to successfully enrol participants. The target of 500 participants was reached on 7th August 2023. Over half of the participants were recruited from the lead site in Oxford.
The primary endpoint for the outcome of the trial was definite treatment failure within a year of randomisation decided by an independent blinded endpoint committee. Analysis showed that there were no more treatment failures in the SHORT arm of the trial than the LONG arm. The same result was observed after taking into consideration participants who did not complete the 12month follow-up due to withdrawal from the study, death or being lost to follow-up.
A secondary endpoint for analysis in the trial was the frequency and severity of side effects from the antibiotics used to treat the bone and joint infections. Diarrhoea, nausea, rash, tiredness and vomiting were specific side effects identified as important by 16 members of a patient focus group before the start of the trial. Antibiotic side effects were compared at 6 weeks and 3-6 months after surgery. Side effects were not compared at 12-months as very few patients with bone or joint infection remain on treatment for that long. Analysis showed that substantially fewer side effects were observed in the SHORT arm of the trial than the LONG arm.
The SOLARIO trial has shown that a short regime (≤7 days) of systemic antibiotics is no worse in terms of treatment failure than the current practice of 4 weeks of systemic antibiotics, if antibiotics are implanted at the site of orthopaedic infection. This result provides scientific evidence to support a reduction in the use of systemic antibiotics when treating bone and joint infections which will help to limit antibiotic resistance. In addition, the SOLARIO trial has shown that patients would benefit from a shorter regime of antibiotics in terms of having fewer side effects.REC name
South Central - Oxford C Research Ethics Committee
REC reference
18/SC/0624
Date of REC Opinion
14 Dec 2018
REC opinion
Favourable Opinion