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

W81XWH2210635

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.

2023-05-30

2025-09-01

2026-09-29

Recruiting

Early phase I

250

Inclusion Criteria: 1. Nonunion of a fracture that has previously undergone fixation. A Nonunion is defined as unplanned surgery with the primary purpose to promote union based on clinical/radiographic evidence \>3 months after last fixation 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arm, randomized controlled multicenter Phase III trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}

2024-03-28