Short or Long Antibiotic Regimes in Orthopaedics
Key facts
- Who runs it
- Oxford University Hospitals NHS Trust
- Where
- Germany, Portugal, Spain, and United Kingdom23 sites in 4 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 500 people enrolled
- Started
- 21 Feb 2019
- Ended
- 31 Jan 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Shorter Systemic Antibiotics
- Standard treatment
- Record updated
- 3 April 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- Surgical exclusion criteria
- The index operation involved implant retention (e.g. DAIR); Microbiological 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
- 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
This trial has no sites in United States.
It has sites in 4 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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?
Read full original descriptionShow less
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. This study investigates whether using local antibiotic therapy would allow shorter courses of oral or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost.
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).
Adults with bone and joint infections who have already had surgery and local antibiotic therapy will be invited. 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.
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.
The 2 groups in the trial
- Shorter Systemic AntibioticsTreatment being tested
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.
- Long Systemic AntibioticsExisting treatment, for comparison
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.
Treatment: Standard treatment
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial
- Record updated
- 3 April 2025