Phase 3 Study Comparing Oral and Intravenous Antibiotics for Treating Infected Non-Healing Bone Fractures After Fixation

What this Trial Is About

Researchers are conducting a Phase III randomized clinical trial to compare oral PO antibiotics versus intravenous IV antibiotics for treating infected unhealed fractures after internal fixation. The study involves 250 adults aged 18 years or older with infected nonunion fractures having a segmental defect less than one centimeter. The goal is to evaluate whether oral antibiotic therapy is as effective as traditional IV therapy when combined with appropriate surgical care. Participants will be randomly assigned to receive either oral or IV antibiotics for 6 weeks following hospital discharge. Alongside antibiotics, all patients will receive standard care including surgical debridement and soft tissue wound coverage. Antibiotic types vary by infection diagnosis and are prescribed by treating physicians medications are obtained through usual health insurance or facility resources. Follow-up includes laboratory evaluations of inflammatory markers at 2 and 6 weeks and clinical and radiographic assessments up to one year. During the study, participants will attend follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months. Researchers will monitor re-hospitalization rates, treatment failure including reinfection and nonunion, complications, amputation, treatment adherence, and costs. Outcome assessments include patient-reported outcomes, physical and psychosocial function, and compliance with antibiotic treatment. The study measures safety and effectiveness over one year after treatment.

PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation