PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Major Extremity Trauma Research Consortium
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.
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 tradition…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 initi…
Interventions
- DrugStandard of Care PO (oral) antibiotics
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.
- DrugStandard of Care Intravenous (IV) antibiotics
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.
Locations (13)
- Indiana UniversityIndianapolis, Indiana
- University of Maryland , MD Department of OrthopaedicsBaltimore, Maryland
- Sinai Hospital BaltimoreBaltimore, Maryland
- Hennepin HealthMinneapolis, Minnesota
- Jamaica Hospital Medical CenterQueens, New York
- Atrium Health, Carolinas Medical CenterCharlotte, North Carolina