Oral versus intravenous antibiotics for bone and joint infection

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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” Li et al (2019).

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 .).. 2019 Jan 31;380(5):425-436. doi: 10.1056/NEJMoa1710926.
Oral versus Intravenous Antibiotics for Bone and Joint Infection.

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Reference:

Li, H.K., Rombach, I., Zambellas, R., Walker, A.S., McNally, M.A., Atkins, B.L., Lipsky, B.A., Hughes, H.C., Bose, D., Kümin, M., Scarborough, C., Matthews, P.C., Brent, A.J., Lomas, J., Gundle, R., Rogers, M., Taylor, A., Angus, B., Byren, I., Berendt, A.R., Warren, S., Fitzgerald, F.E., Mack, D.J.F., Hopkins, S., Folb, J., Reynolds, H.E., Moore, E., Marshall, J., Jenkins, N., Moran, C.E., Woodhouse, A.F., Stafford, S., Seaton, R.A., Vallance, C., Hemsley, C.J., Bisnauthsing, K., Sandoe, J.A.T., Aggarwal, I., Ellis, S.C., Bunn, D.J., Sutherland, R.K., Barlow, G., Cooper, C., Geue, C., McMeekin, N., Briggs, A.H., Sendi, P., Khatamzas, E., Wangrangsimakul, T., Wong, T.H.N., Barrett, L.K., Alvand, A., Old, C.F., Bostock, J., Paul, J., Cooke, G., Thwaites, G.E., Bejon, P. and Scarborough, M. (2019) Oral versus Intravenous Antibiotics for Bone and Joint Infection. The New England Journal of Medicine. 380(5), p.425-436.

doi: 10.1056/NEJMoa1710926.

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