Oral versus intravenous antibiotics for bone and joint infection

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Title: Oral versus intravenous antibiotics for bone and joint infection
Authors: Li, H-K
Rombach, I
Zambellas, R
Walker, AS
McNally, MA
Atkins, BL
Lipsky, BA
Hughes, HC
Bose, D
Kümin, M
Scarborough, C
Matthews, PC
Brent, AJ
Lomas, J
Gundle, R
Rogers, M
Taylor, A
Angus, B
Byren, I
Berendt, AR
Warren, S
Fitzgerald, FE
Mack, DJF
Hopkins, S
Folb, J
Reynolds, HE
Moore, E
Marshall, J
Jenkins, N
Moran, CE
Woodhouse, AF
Stafford, S
Seaton, RA
Vallance, C
Hemsley, CJ
Bisnauthsing, K
Sandoe, JAT
Aggarwal, I
Ellis, SC
Bunn, DJ
Sutherland, RK
Barlow, G
Cooper, C
Geue, C
McMeekin, N
Briggs, AH
Sendi, P
Khatamzas, E
Wangrangsimakul, T
Wong, THN
Barrett, LK
Alvand, A
Old, CF
Bostock, J
Paul, J
Cooke, G
Thwaites, GE
Bejon, P
Scarborough, M
Item Type: Journal Article
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.)
Issue Date: 31-Jan-2019
Date of Acceptance: 19-Dec-2018
ISSN: 0028-4793
Publisher: New England Journal of Medicine (NEJM/MMS)
Start Page: 425
End Page: 436
Journal / Book Title: New England Journal of Medicine
Volume: 380
Issue: 5
Copyright Statement: © 2019 Massachusetts Medical Society. All rights reserved.
Sponsor/Funder: National Institute for Health Research
National Institute for Health Research
Funder's Grant Number: RDB21 79560
Keywords: Science & Technology
Life Sciences & Biomedicine
Medicine, General & Internal
General & Internal Medicine
Administration, Intravenous
Administration, Oral
Aged, 80 and over
Anti-Bacterial Agents
Bone Diseases, Infectious
Intention to Treat Analysis
Joint Diseases
Medication Adherence
Middle Aged
Treatment Outcome
Young Adult
OVIVA Trial Collaborators
11 Medical And Health Sciences
Publication Status: Published
Appears in Collections:Department of Medicine
Faculty of Medicine

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