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Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial

 

Trial Status:  Recruiting

RESEARCH SUMMARY

 

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 is 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.

 

SOLARIO is a multi-centre open label clinical trial comparing long and short antibiotic therapy. To be included in this study, each participant must have had local antibiotics placed into their wound during surgery and their infection must not not have been caused by bacteria that are resistant to the local antibiotic therapy.

 

Participants are being recruited over a three-year period at orthopaedic hospitals in England and Europe.

Trial Opened to Recruitment:  18th February 2019

Recruitment Target:  500

Trial Registration:  NCT03806166

Funding Source:  European Bone and Joint Infection Society

Main contact for this trial:

 

Maria.Dudareva@nhs.net

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