An interventional study of Shorter Systemic Antibiotics and Standard treatment in Osteomyelitis, Prosthetic Joint Infection and Diabetic Foot, sponsored by Oxford University Hospitals NHS Trust. Completed at 23 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.
Sponsored by Oxford University Hospitals NHS Trust · Not applicable, Interventional, and Treatment
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?
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.
Using antibiotics wisely, only when and where they are really needed, is important to prevent superbugs emerging. At the moment, bone and joint infections are usually treated by a combination of surgery and antibiotics. Traditionally, treatment relies on several weeks of antibiotics as tablets or injections (systemic antibiotics), but these can sometimes cause problems.
It is now possible to administer local antibiotics at the time of surgery directly to the site of infection. This allows much higher levels of the antibiotic to be delivered, for days or weeks, following surgery. Therefore, this study will investigate whether local antibiotics with a shorter course of systemic antibiotics can treat bone and joint infections as effectively as local antibiotics with a prolonged course of systemic antibiotics (usual treatment). If so, it may be possible to reduce antibiotic side effects, help to prevent antibiotic resistant bacteria emerging and limit overall treatment costs.
Patients who agree to participate in this study will be allocated at random to two treatment strategies after surgery for bone and joint infection.
One group of patients will be treated with local antibiotics and a long course of systemic antibiotics, which is the usual treatment: this is the 'long group'.
The other group will be treated with local antibiotics and a short course of systemic antibiotics: this is the 'short group' whose treatment differs from the current usual treatment.
Patients will be involved in the study for one year, and infection recurrence will be assessed at the time of routine clinic review up to 12 months after surgery. Whether or not treatment has been successful will be assessed by an independent committee of specialists, who will remain unaware of the patient's allocated treatment strategy.
Presenting with an orthopaedic infection, defined by one or more of the following criteria:
Exclusion Criteria:
Surgical exclusion criteria
The index operation was not a definitive procedure with the aim of eradicating infection:
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
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.
Other: Shorter Systemic Antibiotics
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.
Other: Standard treatment
Reduced duration of post-operative systemic antibiotic therapy
Standard duration of systemic antibiotic treatment
Definitive treatment failure (infection recurrence)
Proportion of participants in each treatment group experiencing definitive treatment failure (infection recurrence), ascertained by an independent committee of experts unaware of the treatment allocation of the participant, according to established criteria.
Time frame: 12 months from the time of surgery for bone or joint infection
Possible or probable treatment failure
Proportion of participants in each treatment group experiencing clinical features suggesting possible or probable infection recurrence, not meeting the definition for definitive treatment failure, determined by an independent committee of experts unaware of treatment allocation, where microbiological culture is not done or is negative. Ascertainment is based on established clinical criteria associated with, but not diagnostic of, orthopaedic infection.
Time frame: 12 months from the time of surgery for bone or joint infection
Serious Adverse Events
Proportion of participants in each treatment group experiencing Serious Adverse Events including mortality
Time frame: 12 months from the time of surgery for bone or joint infection
Antibiotic side effects
Proportion of participants in each treatment group experiencing possible side-effects from systemic antibiotic treatment, adjusted for severity on a 3-point scale
Time frame: This will be assessed at baseline (pre-randomisation, at <7 days of treatment), 6 weeks and 3 months from the time of surgery for bone or joint infection
Quality of life measured by EuroQol 5 Dimensions 5 Levels Score and EuroQol Visual Analogue Score
EQ-5D-5L score distribution across 5 dimensions (mobility, self-care, ability to complete usual activities, pain or discomfort, anxiety or depression) for participants, ranging from 1 (worst) to 5 (best) for each dimension. EQ-VAS score distribution for participants, for self-reported health state, ranging from 0 (worst) to 100 (best).
Time frame: At baseline and 12 months from the time of surgery for bone or joint infection
Plan to share: No
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Oxford University Hospitals NHS Trust