Li and colleagues tested whether oral antibiotics are noninferior to intravenous antibiotics during the first 6 weeks of treatment for bone and joint infection.
Randomized noninferiority trial of 1054 adults with bone or joint infection across 26 UK centers, followed 1 year.
Methods
Design
Randomized noninferiority trial
Randomized within 7 days of surgery, or of starting antibiotics if managed without surgery
Setting
26 UK centers
Patients
1054 adults with bone or joint infection
527 per group
End‑point data available for 1015 (96.3%)
Groups
IV antibiotics for the first 6 weeks
Oral antibiotics for the first 6 weeks
Follow‑on oral antibiotics allowed in both groups
Follow-up
1 year
Primary outcome
Definitive treatment failure by 1 year
Noninferiority margin 7.5 percentage points
Outcomes
Serious adverse events
Catheter complications
Early discontinuation of assigned strategy
Hospital stay
Key Findings
Oral antibiotics were noninferior to IV antibiotics, with a 1‑year treatment failure difference of −1.4 percentage points (90% CI −4.9 to 2.2) against a 7.5‑point margin.
Among participants with end‑point data, treatment failed in 13.2% of the oral group (67 of 509) and 14.6% of the IV group (74 of 506).
Serious adverse events did not differ significantly between groups (27.7% IV vs 26.2% oral, p = 0.58).
Catheter complications occurred in 9.4% of the IV group vs 1.0% of the oral group (49 vs 5 of 523 each, p < 0.001).
Median hospital stay was 14 days with IV therapy vs 11 days with oral therapy (p < 0.001).
No predefined or post hoc subgroup showed an outcome advantage for either route (p > 0.05 for all heterogeneity tests).
Board pearl
OVIVA's noninferiority claim rests on the upper bound of the 90% CI for the oral‑minus‑IV failure difference (2.2 points) lying below the prespecified 7.5‑point margin.
Authors' conclusion
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.
Li and colleagues tested whether oral antibiotics are noninferior to intravenous antibiotics during the first 6 weeks of treatment for bone and joint infection.
Randomized noninferiority trial of 1054 adults with bone or joint infection across 26 UK centers, followed 1 year.
Methods
Design
Randomized noninferiority trial
Randomized within 7 days of surgery, or of starting antibiotics if managed without surgery
Setting
26 UK centers
Patients
1054 adults with bone or joint infection
527 per group
End‑point data available for 1015 (96.3%)
Groups
IV antibiotics for the first 6 weeks
Oral antibiotics for the first 6 weeks
Follow‑on oral antibiotics allowed in both groups
Follow-up
1 year
Primary outcome
Definitive treatment failure by 1 year
Noninferiority margin 7.5 percentage points
Outcomes
Serious adverse events
Catheter complications
Early discontinuation of assigned strategy
Hospital stay
Key Findings
Oral antibiotics were noninferior to IV antibiotics, with a 1‑year treatment failure difference of −1.4 percentage points (90% CI −4.9 to 2.2) against a 7.5‑point margin.
Among participants with end‑point data, treatment failed in 13.2% of the oral group (67 of 509) and 14.6% of the IV group (74 of 506).
Serious adverse events did not differ significantly between groups (27.7% IV vs 26.2% oral, p = 0.58).
Catheter complications occurred in 9.4% of the IV group vs 1.0% of the oral group (49 vs 5 of 523 each, p < 0.001).
Median hospital stay was 14 days with IV therapy vs 11 days with oral therapy (p < 0.001).
No predefined or post hoc subgroup showed an outcome advantage for either route (p > 0.05 for all heterogeneity tests).
Board pearl
OVIVA's noninferiority claim rests on the upper bound of the 90% CI for the oral‑minus‑IV failure difference (2.2 points) lying below the prespecified 7.5‑point margin.
Authors' conclusion
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.