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

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.

NCT Number	NCT05699174
Lead Sponsor	Major Extremity Trauma Research Consortium Collaborators: United States Department of Defense
Conditions	Infections, Infected Wound, Nonunion of Fracture, Injury Leg, Amputation, Internal Fixation; Complications, Infection or Inflammation, Fracture, Lower Extremity Fracture +1 more
Enrollment	250 participants
Start Date	2023-05-30
Primary Completion	2027-09 (estimated)
Study Completion	2028-09-29 (estimated)
Updated on ClinicalTrials.gov	2026-06-11