Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO)
Osteomyelitis, Prosthetic Joint Infection, Diabetic Foot
About this trial
This is an interventional treatment trial for Osteomyelitis
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent
- Aged 18 years or over
Presenting with an orthopaedic infection, defined by one or more of the following criteria:
- localised pain, OR
- localised erythema, OR
- temperature ≥ 38.0 C, OR
- a discharging sinus or wound
- Undergoing surgical treatment for the infection
- Locally administered antibiotic(s) at the site of orthopaedic infection
- Has received <= 7 days of systemic antimicrobial therapy after surgery
- Would ordinarily be managed with a prolonged course (>= 4 weeks) of systemic antibiotic(s)
- Specimens for microbiological analysis taken at index surgery
Exclusion Criteria:
Surgical exclusion criteria
The index operation was not a definitive procedure with the aim of eradicating infection:
- Primary closure has not been achieved, or
- Re-look surgery is planned
The index operation involved implant retention (e.g. DAIR)
Microbiological exclusion criteria
Any identified micro-organisms from operative specimens from the site of incident infection are fully resistant to the local antibiotic(s) administered at the site of infection
Medical exclusion criteria
- Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis
- If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection
Sites / Locations
- Universitaetsklinikum Regensburg
- Hospital San Antonio
- Parc de Salut Mar
- University Hospitals Dorset
- Southampton General Hospital
- Wrightington Hospital
- Royal National Orthopaedic Hospital
- The Robert Jones & Agnes Hunt Hospital
- Bone Infection Unit, Nuffield Orthopaedic Centre
- Great Western Hospital
- University Hospitals Birmingham
- Blackpool Teaching Hospitals NHS Foundation Trust
- Brighton & Sussex University Hospitals NHS Trust
- Royal Liverpool Hospitals
- Barts and the Royal London Hospitals
- London North West Healthcare NHS Trust
- Imperial College Healthcare NHS Trust
- Manchester University NHS Foundation Trust
- Northumbria Healthcare NHS Foundation Trust
- Nottingham University Hospitals NHS Trust
- The Rotherham NHS Foundation Trust
- Salisbury NHS Foundation Trust
- The Mid Yorkshire Hospitals NHS Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Shorter Systemic Antibiotics
Long Systemic Antibiotics
Participants will receive local antibiotic therapy at the time of surgery, followed by one week or less of systemic antibiotic therapy, for bone and joint infection.
Participants will receive local antibiotic therapy at the time of surgery, followed by four weeks or more of systemic antibiotic therapy (standard treatment recommended by international guidelines), for bone and joint infection.