POvIV
Trial question
Is oral antibiotic therapy noninferior to intravenous antibiotic therapy in patients with fracture-related infections?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
23.0% female
77.0% male
N = 233
233 patients (53 female, 180 male).
Inclusion criteria: adult patients hospitalized with fracture-related infections without evidence of osteomyelitis.
Key exclusion criteria: age ≥ 85 years; osteomyelitis; high risk of amputation of the study limb; treatment with any other investigational therapy within months preceding implantation or planned within 12 months following implantation; pathological fractures; receipt of SSRIs.
Interventions
N=115 oral antibiotics (antibiotics by mouth after a deep infection involving hardware for bone fixation).
N=118 intravenous antibiotics (intravenous antibiotics after a deep infection involving hardware for bone fixation).
Primary outcome
Mean number of surgical interventions within 1 year in modified intention-to-treat analysis
1.32 / p-y
1.09 / p-y
1.3/ p-y
1.0/ p-y
0.7/ p-y
0.3/ p-y
0.0/ p-y
Oral
antibiotics
Intravenous
antibiotics
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in mean number of surgical interventions within 1 year in the modified intention-to-treat analysis (1.32/ p-y vs. 1.09/ p-y; MD 0.23, 95% CI -Infinity to 0.59).
Secondary outcomes
No significant difference in the rate of recurrence of deep surgical site infection within 1 year (33.3% vs. 32.5%; AD 0.71%, 95% CI -11.8 to 13.6).
Conclusion
In adult patients hospitalized with fracture-related infections without evidence of osteomyelitis, oral antibiotics were noninferior to intravenous antibiotics with respect to mean number of surgical interventions within 1 year in the modified intention-to-treat analysis.
Reference
Major Extremity Trauma Research Consortium (METRC), William T Obremskey, Robert V O'Toole et al. Oral vs Intravenous Antibiotics for Fracture-Related Infections: The POvIV Randomized Clinical Trial. JAMA Surg. 2025 Jan 22. Online ahead of print.
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