6/28/23, 11:44 PM OVIVA Pathway Feedback Search Clinical Topics Home Studies OVIVA OVIVA Disease Disease Septic arthritis Vertebral osteomyelitis Trial question Are oral antibiotics noninferior to IV antibiotics for bone and joint infection in adults? Study design Multi-center Open label RCT Population Characteristics of study participants 36.0% female N = 1054 64.0% male 1054 patients (376 female, 678 male) Inclusion criteria: patients being treated for bone or joint infection Key exclusion criteria: S. aureus bacteremia, bacterial endocarditis, or any other concomitant infection, mild osteomyelitis, septic shock Interventions N=527 oral antibiotic therapy (for the first 6 weeks of therapy) N=527 IV antibiotic therapy (for the first 6 weeks of therapy) Primary outcome Definitive treatment failure at 1 year 14.6 https://web.pathway.md/studies/recHhgA8hFAOWXmra 1/2 6/28/23, 11:45 PM OVIVA Pathway 6 14.6 % 13.2 10.9 % 7.3 % Difference not exceeding nonferiority margin 3.6 % 0.0 % Oral antibiotic therapy IV antibiotic therapy Difference not exceeding nonferiority margin in definitive treatment failure at 1 year (13.2% vs. 14.6%; ARD -1.4, 95% CI -5.6 to 2.9) Secondary outcomes No significant difference in probable or possible treatment failure (2% vs. 1.2%; ARD 0.7, 95% CI -5.1 to 3.8) Significant decrease in early discontinuation of therapy (12.8% vs. 18.9%; ARD -6.1, 95% CI -10.45 to -1.75) No significant difference in C. difficile infection (1% vs. 1.7%; ARD -0.7, 95% CI -2.2 to 0.6) Safety outcomes No significant differences in serious adverse events (26.2% vs. 27.7%, p=0.58). Conclusion In patients being treated for bone or joint infection, oral antibiotic therapy was noninferior to IV antibiotic therapy with respect to definitive treatment failure at 1 year. Reference Li HK, Rombach I, Zambellas R et al. Oral versus Intravenous Antibiotics for Bone and Joint Infection. N Engl J Med. 2019 Jan 31;380(5):425-436. Open reference URL https://web.pathway.md/studies/recHhgA8hFAOWXmra 2/2