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COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL

Oral versus Intravenous Antibiotics for Bone and Joint Infection

Ho-Kwong Li, Ines Rombach, Rhea Zambellas, A Sarah Walker, Martin A McNally, Bridget L Atkins, Benjamin A Lipsky, Harriet C Hughes, Deepa Bose, Michelle K├╝min, Claire Scarborough, Philippa C Matthews, Andrew J Brent, Jose Lomas, Roger Gundle, Mark Rogers, Adrian Taylor, Brian Angus, Ivor Byren, Anthony R Berendt, Simon Warren, Fiona E Fitzgerald, Damien J F Mack, Susan Hopkins, Jonathan Folb, Helen E Reynolds, Elinor Moore, Jocelyn Marshall, Neil Jenkins, Christopher E Moran, Andrew F Woodhouse, Samantha Stafford, R Andrew Seaton, Claire Vallance, Carolyn J Hemsley, Karen Bisnauthsing, Jonathan A T Sandoe, Ila Aggarwal, Simon C Ellis, Deborah J Bunn, Rebecca K Sutherland, Gavin Barlow, Cushla Cooper, Claudia Geue, Nicola McMeekin, Andrew H Briggs, Parham Sendi, Elham Khatamzas, Tri Wangrangsimakul, T H Nicholas Wong, Lucinda K Barrett, Abtin Alvand, C Fraser Old, Jennifer Bostock, John Paul, Graham Cooke, Guy E Thwaites, Philip Bejon, Matthew Scarborough
New England Journal of Medicine 2019 January 31, 380 (5): 425-436
30699315

BACKGROUND: The management of complex orthopedic infections usually includes a prolonged course of intravenous antibiotic agents. We investigated whether oral antibiotic therapy is noninferior to intravenous antibiotic therapy for this indication.

METHODS: We enrolled adults who were being treated for bone or joint infection at 26 U.K. centers. Within 7 days after surgery (or, if the infection was being managed without surgery, within 7 days after the start of antibiotic treatment), participants were randomly assigned to receive either intravenous or oral antibiotics to complete the first 6 weeks of therapy. Follow-on oral antibiotics were permitted in both groups. The primary end point was definitive treatment failure within 1 year after randomization. In the analysis of the risk of the primary end point, the noninferiority margin was 7.5 percentage points.

RESULTS: Among the 1054 participants (527 in each group), end-point data were available for 1015 (96.3%). Treatment failure occurred in 74 of 506 participants (14.6%) in the intravenous group and 67 of 509 participants (13.2%) in the oral group. Missing end-point data (39 participants, 3.7%) were imputed. The intention-to-treat analysis showed a difference in the risk of definitive treatment failure (oral group vs. intravenous group) of -1.4 percentage points (90% confidence interval [CI], -4.9 to 2.2; 95% CI, -5.6 to 2.9), indicating noninferiority. Complete-case, per-protocol, and sensitivity analyses supported this result. The between-group difference in the incidence of serious adverse events was not significant (146 of 527 participants [27.7%] in the intravenous group and 138 of 527 [26.2%] in the oral group; P=0.58). Catheter complications, analyzed as a secondary end point, were more common in the intravenous group (9.4% vs. 1.0%).

CONCLUSIONS: Oral antibiotic therapy was noninferior to intravenous antibiotic therapy when used during the first 6 weeks for complex orthopedic infection, as assessed by treatment failure at 1 year. (Funded by the National Institute for Health Research; OVIVA Current Controlled Trials number, ISRCTN91566927 .).

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