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

Recruiting now · Phase 3

Conditions studied: Infections, Infected Wound, Nonunion of Fracture, Injury Leg, Amputation, Internal Fixation; Complications, Infection or Inflammation, Fracture, Lower Extremity Fracture, Antibiotic Side Effect

In brief

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.

Key facts

Study ID

NCT05699174

Run by

Major Extremity Trauma Research Consortium

People needed

250

Starts

2023-05-30

Expected to finish

2028-09-29

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 1. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.
• Infection as determined by either
• FRI criteria
• CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon
• Systemic antibiotic treatment regimen scheduled for at least 6 weeks

You may not qualify if…

• Patients with a high risk of amputation based on the initial managing physician
• Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment
• Incarcerated or institutionalized patients
• Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic
• Patients with a prior history of chronic infection at the index site before fracture fixation
• Patients with pathological fractures from a neoplastic process
• History of Paget's Disease
• The patient, or a designated proxy, unwilling to provide consent
• The patient must be available for follow-up for at least 12 months following infection treatment

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States (enrolling)
• University of Maryland , MD Department of Orthopaedics — Baltimore, Maryland, United States (enrolling)
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States (enrolling)
• Penn State University M.S. Hershey Medical Center — Hershey, Pennsylvania, United States (enrolling)
• Vanderbilt Medical Center — Nashville, Tennessee, United States (enrolling)
• University of Washington Harborview Medical Center — Seattle, Washington, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Hennepin Health — Minneapolis, Minnesota, United States (enrolling)
• Sinai Hospital Baltimore — Baltimore, Maryland, United States
• University of Okalahoma College of Medicine — Oklahoma City, Oklahoma, United States
• Jamaica Hospital Medical Center — Queens, New York, United States
• Atrium Health, Carolinas Medical Center — Charlotte, North Carolina, United States
• University of Texas Health Science Center at Houston — Houston, Texas, United States

Full record on ClinicalTrials.gov

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