Oral versus intravenous antibiotics for the treatment of bone and joint infection (OVIVA): a multicentre randomised controlled trial

Scarborough, M. et al. (2017) Oral versus intravenous antibiotics for the treatment of bone and joint infection (OVIVA): a multicentre randomised controlled trial. 36th Annual Meeting of the European Bone and Joint Infection Society, Nantes, France, 7-9 Sep 2017.

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Abstract

Aim: Current standard of care in the management of bone and joint infection commonly includes a 4–6 week course of intravenous (IV) antibiotics but there is little evidence to suggest that oral antibiotic therapy results in worse outcomes. The primary objective was to determine whether oral antibiotics are non-inferior to IV antibiotics in this setting. Method: This was a parallel group, randomised (1:1), open label, non-inferiority trial across twenty-six NHS hospitals in the United Kingdom. Eligible patients were adults with a clinical diagnosis of bone, joint or orthopaedic metalware-associated infection who would ordinarily receive at least six weeks of antibiotics and who had received ≤7 days of IV therapy from the date of definitive surgery (or the start of planned curative treatment in patients managed non-operatively). Participants were randomised to receive either oral or IV antibiotics for the first 6 weeks of therapy. Follow-on oral therapy was permitted in either arm. The primary outcome was the proportion of participants experiencing definitive treatment failure within one year of randomisation. The non-inferiority margin was set at 7.5%. Results: Of 1054 participants randomised (527 to each arm) endpoint data were available for 1015 (96.30%). Definitive treatment failure was identified in 141/1015 (13.89%) participants, 74/506 (14.62%) of those randomised to IV therapy and 67/509 (13.16%) of those randomised to oral therapy. In the intention to treat analysis, the imputed risk difference (PO-IV) for definitive treatment failure was −1.38% (90% CI: −4.94, 2.19), thus meeting the non-inferiority criterion (i.e. the upper limit of 95%CI being <7.5%). A complete cases analysis, a per-protocol analysis and sensitivity analyses for missing data confirmed this result. With the exception of intravenous catheter complications, there was no significant difference between the two arms in the incidence of serious adverse events (SAEs). Health economic analysis suggests that the non-surgical treatment costs over one year for patients randomised to oral therapy were approximately £2,700 less than those of IV therapy. Conclusions: Oral antibiotic therapy is non-inferior to IV therapy when used during the first six weeks in the treatment for bone and joint infection, as assessed by definitive treatment failure within one 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.

Item Type:Conference or Workshop Item
Additional Information:Abstract published in Orthopaedic Proceedings 99-B(S22), https://dz.doi.org/10.1302/1358-992X.2017.22.042
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Mcmeekin, Mrs Nicola and Geue, Dr Claudia
Authors: Scarborough, M., Li, H.K., Rombach, I., Zambellas, R., Walker, S., Kumin, M., Lipsky, B.A., Hughes, H., Bose, D., Warren, S., Geue, C., Mcmeekin, N., Woodhouse, A., Atkins, B., McNally, M., Berendt, T., Angus, B., Byren, I., Thwaites, G., and Bejon, P.
College/School:College of Medical Veterinary and Life Sciences > Institute of Health and Wellbeing > Health Economics and Health Technology Assessment

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