Oral versus Intravenous Antibiotics for Bone and Joint Infection



Li, H-K, Rombach, I, Zambellas, R, Walker, AS, McNally, MA, Atkins, BL, Lipsky, BA, Hughes, HC, Bose, D, Kumin, M
et al (show 49 more authors) (2019) Oral versus Intravenous Antibiotics for Bone and Joint Infection. NEW ENGLAND JOURNAL OF MEDICINE, 380 (5). pp. 425-436.

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Abstract

<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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%).<h4>Conclusions</h4>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
Uncontrolled Keywords: OVIVA Trial Collaborators, Humans, Bone Diseases, Infectious, Joint Diseases, Anti-Bacterial Agents, Treatment Outcome, Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Medication Adherence, Young Adult, Intention to Treat Analysis, Administration, Intravenous
Depositing User: Symplectic Admin
Date Deposited: 21 Aug 2019 08:28
Last Modified: 19 Jan 2023 00:28
DOI: 10.1056/NEJMoa1710926
Open Access URL: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC65223...
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3052205