OVIVA
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
64.0% male
N = 1054
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
13.2%
14.6%
14.6 %
10.9 %
7.3 %
3.6 %
0.0 %
Oral antibiotic
therapy
IV antibiotic
therapy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority 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.
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