Short or Long Antibiotic Regimes in Orthopaedics
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetic Foot
- Osteomyelitis
- Prosthetic Joint Infection
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Non-inferiority randomised controlled trialMasking: Single (Outcomes Assessor)Masking Description: Ascertainment of the primary outcome (treatment failure) will be undertaken by an independent committee of specialists, using redacted participant clinical records, who will remain unaware of the treatment allocation of the participant, and who will ascertain treatment failure according to established objective criteria.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 in...
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.
Tracking Information
- NCT #
- NCT03806166
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Matthew Scarborough Oxford University Hospitals