OVIVA (Oral Versus Intravenous Antibiotics for Bone and Joint Infection)
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The OVIVA Trial (funded by the NIHR Health Technology Assessment Programme) is a multi-centre randomised controlled trial to measure the clinical and cost effectiveness of oral and intravenous antibiotics for the treatment of bone and joint infections.
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.
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.
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.
OVIVA Inclusion Criteria
The participant must meet each of the following inclusion criteria:
- A clinical syndrome comprising any of the following:
- localized pain OR
- localized erythema OR
- temperature >38.0°C OR
- a discharging sinus or wound AND
- willing and able to give informed consent AND
- aged 18 years or above AND
- the patient has received 7 days or less of intravenous therapy after an appropriate surgical intervention to treat bone or joint infection (regardless of pre-surgical antibiotics) or, if no surgical intervention is required, the patient has received 7 days or less of intravenous therapy after the start of the relevant clinical episode.
- has a life expectancy > 1 year AND
- has a bone and joint infection in one of the following categories:
- Native osteomyelitis (i.e., bone infection without metalwork) including haematogenous or contiguous osteomyelitis, and long bone, skull, foot or other foci OR
- Native joint sepsis treated by excision arthroplasty OR
- Prosthetic joint infection treated by debridement and retention, by one stage revision or by excision of the prosthetic joint (with or without planned re-implantation) OR
- Orthopaedic device or bone-graft infection treated by debridement and retention, or by debridement and removal OR
- Spinal infection including discitis, osteomyelitis and / or epidural abscess.
OVIVA Exclusion Criteria
The participant may not enter the study if ANY one of the following applies:
- Staphylococcus aureus bacteraemia on presentation or within the last 1 month OR
- bacterial endocarditis on presentation or within the last month (NB there are no study mandated investigations. Participants are not required to have echocardiograms, blood cultures, or any other investigations to exclude endocarditis in the absence of a clinical indication) OR
- Any other concomitant infection which, in the opinion of the clinician responsible for the patient, required a prolonged intravenous course of antibiotics (e.g. mediastinal infection or central nervous system infection) OR
- Mild osteomyelitis, defined as osteomyelitis which, in the opinion of the clinical investigator, would not usually require a 6 week course of intravenous antibiotics OR
- An infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics, which occurred in <5% of patients during recruitment for our pilot study) OR
- Previous enrolment in the trial OR
- Septic shock or systemic features requiring intravenous antibiotics in the opinion of the treating clinician (the patient may be re-evaluated if these features resolve) OR
- The patient is unlikely to comply with trial requirements following randomization (including specific requirement for PO or IV course) in the opinion of the investigator OR
- There is clinical, histological or microbiological evidence of mycobacterial, fungal, parasitic or viral etiology OR
- The patient is receiving an investigational medical product as part of another clinical trial.
The use of antibiotic-loaded cement in spacers or beads at the site of infection will not be an exclusion criteria, but will be recorded in baseline data. Pregnancy, renal failure and liver failure will not be exclusion criteria provided suitable antibiotic choices can be identified.