1. Oral versus intravenous antibiotics for bone and joint infection
- Author
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John Marshall, Gavin Barlow, A S Walker, S C Ellis, Abtin Alvand, Lucinda Barrett, Susan Hopkins, Jennifer Bostock, Philippa C Matthews, John Paul, D J Bunn, Adrian Taylor, Claudia Geue, E Khatamzas, Parham Sendi, S Warren, M Rogers, B Atkins, Rhea Zambellas, S Stafford, C E Moran, Sandoe Jat., I. Byren, Graham S Cooke, N. Jenkins, M Scarborough, R K Sutherland, Andrew Brent, Harriet Hughes, C Vallance, Helen Reynolds, Guy E. Thwaites, A F Woodhouse, J Folb, Benjamin A. Lipsky, I Aggarwal, C Scarborough, Tri Wangrangsimakul, R.A. Seaton, Wong Thn., F E Fitzgerald, Roger Gundle, C F Old, Cyrus Cooper, Michelle Kümin, Anthony R. Berendt, K Bisnauthsing, Ines Rombach, Andrew Briggs, Martin A. McNally, Mack Djf., Nicola McMeekin, Elinoor Moore, J Lomas, Philip Bejon, Brian Angus, Li H-K., C J Hemsley, D Bose, and National Institute for Health Research
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Treatment outcome ,Medication adherence ,Administration, Oral ,030204 cardiovascular system & hematology ,Article ,law.invention ,Medication Adherence ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,Medicine, General & Internal ,Randomized controlled trial ,law ,Internal medicine ,General & Internal Medicine ,OSTEOMYELITIS ,medicine ,MANAGEMENT ,Humans ,030212 general & internal medicine ,610 Medicine & health ,Aged ,Aged, 80 and over ,Intention-to-treat analysis ,Science & Technology ,business.industry ,General Medicine ,11 Medical And Health Sciences ,Middle Aged ,Bone Diseases, Infectious ,Anti-Bacterial Agents ,Intention to Treat Analysis ,Editorial Commentary ,Treatment Outcome ,Multicenter study ,Intravenous antibiotics ,Oral antibiotic therapy ,Orthopedic surgery ,570 Life sciences ,biology ,OVIVA Trial Collaborators ,Administration, Intravenous ,Female ,Joint Diseases ,business ,Life Sciences & Biomedicine - Abstract
BACKGROUND\ud \ud 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.\ud \ud \ud \ud METHODS\ud \ud 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.\ud \ud \ud \ud RESULTS\ud \ud 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%).\ud \ud \ud \ud CONCLUSIONS\ud \ud 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. opens in new tab.)
- Published
- 2018