Short or Long Antibiotic Regimes in Orthopaedics

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.

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