Li, Ho-Kwong; Rombach, Ines; Zambellas, Rhea; Walker, A Sarah; McNally, Martin A; Atkins, Bridget L; Lipsky, Benjamin A; Hughes, Harriet C; Bose, Deepa; Kümin, Michelle; +50 more... Scarborough, Claire; Matthews, Philippa C; Brent, Andrew J; Lomas, Jose; Gundle, Roger; Rogers, Mark; Taylor, Adrian; Angus, Brian; Byren, Ivor; Berendt, Anthony R; Warren, Simon; Fitzgerald, Fiona E; Mack, Damien JF; Hopkins, Susan; Folb, Jonathan; Reynolds, Helen E; Moore, Elinor; Marshall, Jocelyn; Jenkins, Neil; Moran, Christopher E; Woodhouse, Andrew F; Stafford, Samantha; Seaton, R Andrew; Vallance, Claire; Hemsley, Carolyn J; Bisnauthsing, Karen; Sandoe, Jonathan AT; Aggarwal, Ila; Ellis, Simon C; Bunn, Deborah J; Sutherland, Rebecca K; Barlow, Gavin; Cooper, Cushla; Geue, Claudia; McMeekin, Nicola; Briggs, Andrew H; Sendi, Parham; Khatamzas, Elham; Wangrangsimakul, Tri; Wong, TH Nicholas; Barrett, Lucinda K; Alvand, Abtin; Old, C Fraser; Bostock, Jennifer; Paul, John; Cooke, Graham; Thwaites, Guy E; Bejon, Philip; Scarborough, Matthew; OVIVA Trial Collaborators; (2019) Oral versus Intravenous Antibiotics for Bone and Joint Infection. NEW ENGLAND JOURNAL OF MEDICINE, 380 (5). pp. 425-436. ISSN 0028-4793 DOI: https://doi.org/10.1056/NEJMoa1710926
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Abstract
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 .).
Item Type | Article |
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Faculty and Department | Faculty of Public Health and Policy > Dept of Health Services Research and Policy |
PubMed ID | 30699315 |
Elements ID | 136580 |