The OVIVA Trial is funded by the NIHR Health Technology Assessment Programme
HTA Project Reference: 11/36/29
To determine whether oral antibiotics are non-inferior to intravenous antibiotics for serious bone and joint infection judged by the percentage of patients experiencing definitive treatment failure during 1 year of follow up.
Background
Bone and joint infections are common in the UK. In the NHS, 100,000 primary joint replacements and 20,000 femoral neck and long bone repairs are performed each year. Infection of bone or joint complicates around 2000 (2%) of these procedures, resulting in disproportionately increased mortality, disability and suffering. Treating these infections costs the NHS hundreds of thousands of pounds each year.
To treat these infections, patients are frequently required to undergo a prolonged course of intravenous (IV) antibiotic therapy. This is often inconvenient for the patients and very costly for the NHS. The evidence supporting this practice is very limited. Previous research indicates that a course of oral antibiotics may be just as effective as the IV treatment. There are currently no large randomised trials comparing these treatments and therefore practice has not changed.
OVIVA provides an opportunity to assess the effectiveness of these treatments. 1050 patients will be recruited from 18 centres across the UK.
Aims
To determine whether oral antibiotics are non-inferior to intravenous antibiotics for serious bone and joint infection judged by the percentage of patients experiencing definitive treatment failure during 1 year of follow up.
Method
This is a pragmatic, randomised controlled trial comparing oral antibiotics with IV antibiotics in the treatment of bone and joint infections. We aim to recruit 1050 patients from 18 centres across the UK. Information to be collected includes:
- Re-infection rates
- Serious Adverse Events
- Patient Reported Outcome Measures
- Quality of Life
Participants will be considered for inclusion when an infectious disease physician reviews a patient with bone or joint infection. The contact will be triggered by routine care pathway, e.g., a referral by the team caring for the patient, a referral from primary care direct to infectious disease services, or by following up a laboratory result.