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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Oral versus intravenous antibiotics for bone and joint infections: The OVIVA non-inferiority RCT
Health Technology Assessment, Volume 23, No. 38, Year 2019
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Description
Background: Management of bone and joint infection commonly includes 4–6 weeks of intravenous (IV) antibiotics, but there is little evidence to suggest that oral (PO) therapy results in worse outcomes. Objective: To determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating bone and joint infection. Design: Parallel-group, randomised (1: 1), open-label, non-inferiority trial. The non-inferiority margin was 7.5%. Setting: Twenty-six NHS hospitals. Participants: Adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least 6 weeks of antibiotics, and who had received ≤ 7 days of IV therapy from definitive surgery (or start of planned curative treatment in patients managed non-operatively). Interventions: Participants were centrally computer-randomised to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy was permitted in either arm. Main outcome measure: The primary outcome was the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation assessed health resource use and quality-of-life data. Results: Out of 1054 participants (527 in each arm), end-point data were available for 1015 (96.30%) participants. Treatment failure was identified in 141 out of 1015 (13.89%) participants: 74 out of 506 (14.62%) and 67 out of 509 (13.16%) of those participants randomised to IV and PO therapy, respectively. In the intention-to-treat analysis, using multiple imputation to include all participants, the imputed risk difference between PO and IV therapy for definitive treatment failure was –1.38% (90% confidence interval –4.94% to 2.19%), thus meeting the non-inferiority criterion. A complete-case analysis, a per-protocol analysis and sensitivity analyses for missing data each confirmed this result. With the exception of IV catheter complications [49/523 (9.37%) in the IV arm vs. 5/523 (0.96%) in the PO arm)], there was no significant difference between the two arms in the incidence of serious adverse events. PO therapy was highly cost-effective, yielding a saving of £2740 per patient without any significant difference in quality-adjusted life-years between the two arms of the trial. Limitations: The OVIVA (Oral Versus IntraVenous Antibiotics) trial was an open-label trial, but bias was limited by assessing all potential end points by a blinded adjudication committee. The population was heterogenous, which facilitated generalisability but limited the statistical power of subgroup analyses. Participants were only followed up for 1 year so differences in late recurrence cannot be excluded. Conclusions: PO antibiotic therapy is non-inferior to IV therapy when used during the first 6 weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within 1 year of randomisation. These findings challenge the current standard of care and provide an opportunity to realise significant benefits for patients, antimicrobial stewardship and the health economy. Future work: Further work is required to define the optimal total duration of therapy for bone and joint infection in the context of specific surgical interventions. Currently, wide variation in clinical practice suggests significant redundancy that likely contributes to the excess and unnecessary use of antibiotics. Trial registration: Current Controlled Trials ISRCTN91566927. © Queen’s Printer and Controller of HMSO 2019.
Authors & Co-Authors
Scarborough, Matthew
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Li, Hokwong
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
United Kingdom, London
Imperial College London
Rombach, Ines
United Kingdom, Oxford
University of Oxford
Zambellas, Rhea
United Kingdom, Oxford
University of Oxford
Walker, Anne Sarah
United Kingdom, London
Mrc Clinical Trials Unit
United Kingdom, Oxford
University of Oxford
McNally, Martin A.
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Atkins, Bridget L.
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Kümin, Michelle
United Kingdom, Oxford
University of Oxford
Lipsky, Benjamin A.
United Kingdom, Oxford
University of Oxford
Hughes, Harriet C.
United Kingdom, Cardiff
Public Health Wales
Bose, Deepa
United Kingdom, Birmingham
University Hospitals Birmingham Nhs Foundation Trust
Warren, Simon S.
United Kingdom, Stanmore
Royal National Orthopaedic Hospital Nhs Trust
United Kingdom, London
Royal Free London Nhs Foundation Trust
MacK, Damien J.F.
United Kingdom, Stanmore
Royal National Orthopaedic Hospital Nhs Trust
United Kingdom, London
Royal Free London Nhs Foundation Trust
Folb, Jonathan E.
United Kingdom, Liverpool
Liverpool University Hospitals Nhs Foundation Trust
Moore, Elinor R.
United Kingdom, Cambridge
Cambridge University Hospitals Nhs Foundation Trust
Jenkins, Neil
United Kingdom, Birmingham
University Hospitals Birmingham Nhs Foundation Trust
Hopkins, Susan M.
United Kingdom, London
Royal Free London Nhs Foundation Trust
Seaton, Ronald Andrew
United Kingdom, Glasgow
Nhs Greater Glasgow and Clyde
Hemsley, Carolyn J.
United Kingdom, London
Guy's and st Thomas' Nhs Foundation Trust
Sandoe, Jonathan A.T.
United Kingdom, Leeds
Leeds Teaching Hospitals Nhs Trust
Aggarwal, Ila
United Kingdom, Dundee
Nhs Tayside
Ellis, Simon C.
United Kingdom, North Shields
Northumbria Healthcare Nhs Foundation Trust
Sutherland, Rebecca K.
United Kingdom, Edinburgh
Nhs Lothian
Geue, Claudia
United Kingdom, Glasgow
University of Glasgow
McMeekin, Nicola
United Kingdom, Glasgow
University of Glasgow
Scarborough, Claire
United Kingdom, Oxford
University of Oxford
Paul, John M.
United Kingdom, London
Public Health England
Cooke, Graham S.
United Kingdom, London
Imperial College London
Bostock, Jennifer L.
United Kingdom, London
King's College London
Khatamzas, Elham
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Brent, Andrew J.
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Lomas, José Manuel
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Matthews, Philippa C.
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
United Kingdom, Oxford
University of Oxford
Wangrangsimakul, Tri
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Gundle, Roger
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Rogers, Mark
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Taylor, Adrian H.
United Kingdom, Oxford
Oxford University Hospitals Nhs Foundation Trust
Thwaites, G. E.
United Kingdom, Oxford
University of Oxford
Bejon, Philip A.
United Kingdom, Oxford
University of Oxford
Statistics
Citations: 26
Authors: 39
Affiliations: 19
Identifiers
Doi:
10.3310/hta23380
ISSN:
13665278
Research Areas
Health System And Policy
Study Design
Randomised Control Trial
Cross Sectional Study
Cohort Study
Study Approach
Quantitative