PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Status:
Not yet recruiting
Trial end date:
2026-09-29
Target enrollment:
Participant gender:
Summary
This is a Phase III clinical randomized control trial to investigate differences between
patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will
be 250 patients, 18 years or older, being treated for infected nonunion after internal
fixation of a fracture with a segmental defect less than one centimeter. Patients will be
randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control
group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness
of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for
the treatment of infected nonunion after fracture internal fixation, when such therapy is
combined with appropriate surgical management. Clinical effectiveness will be measured as the
primary outcome as the number of secondary re-admissions related to injury and secondary
outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the
first one year of follow-up, as defined by specified criteria and determined by a blinded
data assessment panel. In addition, treatment compliance, the cost of treatment, the number
of surgeries required, the type and incidence of complications, and the duration of
hospitalization will be measured.