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

Launched by MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different ways to treat infections that occur in broken bones that haven’t healed properly after surgery. Specifically, it compares the effectiveness of oral antibiotics (pills) to intravenous (IV) antibiotics (given through a vein) for patients with infected nonunion fractures. The study will include 250 adults who are at least 18 years old and have had a fracture that didn't heal as expected, and they must have an infection that needs treatment for at least 6 weeks. Participants will be randomly assigned to receive either oral or IV antibiotics for the same duration.

To be eligible for the trial, patients must have a fracture that didn't heal properly despite previous surgery and must have a diagnosed infection. However, some individuals may be excluded, such as those at high risk for amputation or those with certain medical conditions. Throughout the study, participants will receive care and have regular follow-ups for at least a year to monitor their recovery and any potential complications. The goal is to see if oral antibiotics can work just as well as IV antibiotics in treating these infections and to understand the broader impacts, like costs and hospitalization time.

Gender

ALL

Eligibility criteria

• 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