Oral vs Intravenous Antibiotics for Fracture-Related Infections: The POvIV Randomized Clinical Trial

Area of Science:

• Orthopedic Surgery
• Infectious Diseases
• Clinical Trials

Background:

• Fracture-related infection (FRI) is a significant complication after fracture fixation surgery.
• Current treatment involves debridement and 6 weeks of intravenous (IV) antibiotics.
• Oral antibiotics present a potentially less expensive and safer alternative.

Purpose of the Study:

• To compare the effectiveness of oral versus IV antibiotics for treating FRI.
• To evaluate noninferiority of oral antibiotics to IV antibiotics in terms of surgical interventions required.

Main Methods:

• A multicenter, prospective randomized clinical trial (POvIV) involving 233 patients.
• Patients received either oral or IV antibiotics for FRI treatment.
• Primary outcome: number of surgical interventions within 1 year; secondary outcome: recurrence of infection.

Main Results:

• Oral antibiotics were noninferior to IV antibiotics based on the primary outcome (number of surgical interventions) in the modified intent-to-treat (mITT) analysis.
• The upper bound of the confidence interval for the difference in surgical interventions was below the noninferiority margin.
• Secondary analyses, including per-protocol and post hoc mITT, showed some uncertainty, but a similar pattern for reinfection rates was observed.

Conclusions:

• Oral antibiotic treatment demonstrated noninferiority to IV treatment for FRI in the primary analysis.
• While secondary analyses indicated some uncertainty, the findings support oral antibiotics as a viable treatment option.
• Further investigation may be warranted to fully clarify the role of oral antibiotics in FRI management.