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SOLARIOlogo.png

SHORT OR LONG ANTIBIOTIC REGIMES IN ORTHOPAEDICS (SOLARIO): A RANDOMISED OPEN LABEL MULTI-CENTRE CLINICAL TRIAL

Status:  Complete

Recruited:  500 across 25 sites

Registration:  NCT03806166

Funding:                                                EBJIS                                                        BMA Kathleen Harper

SOLARIO was a multi-centre open label clinical trial that compared long and short antibiotic therapy. Adults with bone or joint infections are usually treated with surgery followed by a long course of antibiotics, given either through tablets or directly by injection into a vein following surgery, normally for 4 weeks or more. This is called systemic antibiotic therapy. It is now also safe to place antibiotics directly into the affected bone or joint during the operation to remove the infected tissue. This is called local antibiotic therapy and is increasingly used in addition to systemic antibiotic therapy but not on its own.

The aim of this study was to investigate whether it is possible to reduce the 4 weeks or more of systemic antibiotics to 7 days or less. This would help to reduce the side effects sometimes experienced with long courses of antibiotics and help to prevent the emergence of antibiotic resistance through the overuse of antibiotics and it would also make savings for the health economy.

Each participant included in the SOLARIO trial had local antibiotics placed into their wound during surgery and their infection was not caused by bacteria that were resistant to the local antibiotic therapy. Participants were recruited from orthopaedic hospitals in the UK, Portugal, Spain, Austria and Germany.

The main findings of the SOLARIO trial are that, in the presence of local antibiotics, a short regime (≤7 days) of systemic antibiotics is non-inferior to current practice (³4 weeks of systemic antibiotics) when treating orthopaedic infection. In addition, there are substantially fewer side effects with a short regime (≤7 days) of systemic antibiotics.

We anticipate that these findings will benefit patients, limit resistance selection and thereby improve antimicrobial stewardship. 

 

Main Contact:  michelle.kumin@ndm.ox.ac.uk 

 

Publications:

Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a Randomised Controlled Open-Label Non-Inferiority Trial of Duration of Systemic Antibiotics in Adults with Orthopaedic Infection Treated Operatively with Local Antibiotic Therapy. Dudareva, M et al. Trials. (2019) 20: p. 693-702

 

Results paper forthcoming