RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Major Extremity Trauma Research Consortium • ClinicalTrials.gov ID: NCT05699174

Registry updated: 2026-09-11

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Description

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.

Interventions

Standard of Care PO (oral) antibiotics (Drug)
An intervention in this study includes randomization of patients with an infected nonunion to PO (oral) antibiotics for up to 6 weeks post hospitalization. The exact type of oral antibiotic will be depended on the patient's infection diagnosis.
Standard of Care Intravenous (IV) antibiotics (Drug)
An intervention in this study includes randomization of patients with an infected nonunion to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. The exact type of IV antibiotic will be depended on the patient's infection diagnosis.

Eligibility criteria

Inclusion Criteria: 1. 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. 2. Infection as determined by either 1. FRI criteria 2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon 3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks Exclusion Criteria: 1. Patients with a high risk of amputation based on the initial managing physician 2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment 3. Incarcerated or institutionalized patients 4. Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic 5. Patients with a prior history of chronic infection at the index site before fracture fixation 6. Patients with pathological fractures from a neoplastic process 7. History of Paget's Disease 8. The patient, or a designated proxy, unwilling to provide consent 9. The patient must be available for follow-up for at least 12 months following infection treatment

Conditions

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

Locations

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

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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