"Oral versus Intravenous Antibiotics for Bone and Joint Infection (OVIVA)". The New England Journal of Medicine. 2019.
Links to original sources: Wiki Journal Post Full Journal Article
Is oral antibiotic therapy noninferior to intravenous antibiotic therapy for the treatment of bone or joint infection?
Oral antibiotic therapy was noninferior to intravenous antibiotic therapy for the initial 6 weeks of treatment for bone and joint infection when assessed for treatment failure at 1 year.
The standard treatment for complex bone and joint infections typically includes a prolonged course of intravenous antibiotics. The OVIVA trial examined whether oral antibiotic therapy for the first 6 weeks is noninferior to intravenous therapy in adults being treated for bone or joint infection. The trial found that oral therapy was indeed noninferior to intravenous therapy based on rates of definitive treatment failure within 1 year after randomization. Additionally, oral therapy was associated with shorter hospital stays and fewer complications related to intravenous catheters.
As a result of this trial, a standard care practice which favored intravenous antibiotics for bone and joint infections may be re-evaluated, although patient and pathogen-specific factors must be taken into account for therapy decisions.
- Multicenter, open-label, parallel-group, randomized, controlled noninferiority trial - N=1,054 participants - 6 weeks initial treatment period followed by a 1-year assessment for treatment failure - Intravenous antibiotics (n=527) vs. oral antibiotics (n=527) - Enrollment: June 2010 - October 2015
- Participants: Adults being treated for bone or joint infection - Inclusion criteria: Age over 18 years, with bone or joint infection, and consent provided - Exclusion criteria: Infection not managed by surgical intervention within 7 days after the start of antibiotic therapy - Baseline characteristics: Well-matched for age, gender, infection type, and other variables
- Intravenous group: Intravenous antibiotics for the first 6 weeks - Oral group: Oral antibiotics for the first 6 weeks - Follow-on oral antibiotics were permitted post-6-weeks in both groups
- Primary Outcome: Definitive treatment failure within 1 year after randomization - Secondary Outcomes: Early discontinuation of treatment, catheter complications, serious adverse events, the length of hospital stay, adherence to treatment, and patient-reported outcome measures
- The trial was open-label and not blinded - Selection of appropriate oral agents relied on specialist oversight, which may not be consistently applied across different healthcare settings - Study duration was only 1 year, thus later treatment failures beyond this period may not have been captured
- National Institute for Health Research - NIHR Imperial College Biomedical Research Centre - NIHR Oxford Biomedical Research Centre
- NEJM article link: [Link to article] - Supplementary material and appendices for the OVIVA trial, detailing full protocol, methodological justifications, and further statistical analyses