Oral versus intravenous antibiotic treatment for bone and joint infections (OVIVA): study protocol for a randomised controlled trial

• DOI: 10.1186/s13063-015-1098-y
• Publication Date: 2015-12-21T07:48:16Z
• Authors: Ho Kwong Li; Matthew Scarborough; Rhea Zambellas; Cushla Cooper; Ines Rombach; A. Sarah Walker; Benjamin A. Lipsky; Andrew Briggs; Andrew Seaton; Bridget Atkins; Andrew Woodhouse; Anthony Berendt; Ivor Byren; Brian Angus; Hemant Pandit; David Stubbs; Martin McNally; Guy Thwaites; Philip Bejon
• Keywords: Joint infections

Bone and joint infection in adults arises most commonly as a complication of replacement surgery, fracture fixation diabetic foot infection. The associated morbidity can be devastating to patients costs the National Health Service an estimated £20,000 £40,000 per patient. Current standard care UK centres includes prolonged course (4-6 weeks) intravenous antibiotics supported, if available, by outpatient parenteral antibiotic therapy service. Intravenous carries with it substantial risks inconvenience patients, antibiotic-related are approximately ten times that oral therapy. Despite this, there is no evidence suggest results inferior outcomes. We hypothesise that, selecting agents high bioavailability, good tissue penetration activity against known or likely pathogens, key outcomes managed primarily non-inferior those treated therapy.The OVIVA trial parallel group, randomised (1:1), un-blinded, non-inferiority conducted thirty hospitals across UK. Eligible participants (>18 years) clinical syndrome consistent bone, metalware-associated who have received ≤7 days from date definitive surgery (or start planned curative without surgical intervention). Participants receive either antibiotics, selected specialist physician, for first 6 weeks primary outcome measure definite treatment failure within one year randomisation, assessed blinded endpoint committee, according pre-defined microbiological, histological criteria. Enrolling 1,050 subjects will provide 90 % power demonstrate non-inferiority, defined less than 7.5 absolute increase rate compared (one-sided alpha 0.05).If our orally administered therapy, this facilitate dramatically improved patient experience alleviate financial burden on healthcare services.ISRCTN91566927 - 14/02/2013.