Comparing oral and intravenous antibiotics for treating infected nonunion of fractures
PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
This study is testing whether taking antibiotics by mouth works as well as getting them through an IV for people with infected fractures that haven't healed properly after surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Major Extremity Trauma Research Consortium Academic / other |
| Locations | 13 sites (Indianapolis, Indiana and 12 other locations) |
| Trial ID | NCT05699174 on ClinicalTrials.gov |
What this trial studies
This Phase III clinical trial aims to compare the effectiveness of oral antibiotics versus intravenous antibiotics in treating infected nonunion of fractures after surgical fixation. The study will enroll 250 patients aged 18 and older who have experienced an infected nonunion following internal fixation of a fracture. Participants will be randomly assigned to receive either oral antibiotics for six weeks or intravenous antibiotics for the same duration. The primary outcome will assess clinical effectiveness based on the number of secondary re-admissions and treatment failures within one year, alongside other metrics such as treatment compliance and hospitalization duration.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with an infected nonunion of a fracture that has undergone previous fixation.
Not a fit: Patients at high risk of amputation or those with significant comorbidities that prevent treatment with general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more convenient oral antibiotic treatment option for patients with infected nonunion of fractures.
How similar studies have performed: Previous studies have shown promising results with oral antibiotics for various infections, but this specific comparison in the context of infected nonunion is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana and 12 other locations
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- University of Maryland , MD Department of Orthopaedics — Baltimore, Maryland, United States (Recruiting)
- Sinai Hospital Baltimore — Baltimore, Maryland, United States (Not_yet_recruiting)
- Hennepin Health — Minneapolis, Minnesota, United States (Recruiting)
- Jamaica Hospital Medical Center — Queens, New York, United States (Not_yet_recruiting)
- Atrium Health, Carolinas Medical Center — Charlotte, North Carolina, United States (Not_yet_recruiting)
- Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- University of Okalahoma College of Medicine — Oklahoma City, Oklahoma, United States (Not_yet_recruiting)
- Penn State University M.S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
- Vanderbilt Medical Center — Nashville, Tennessee, United States (Recruiting)
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Not_yet_recruiting)
- University of Washington Harborview Medical Center — Seattle, Washington, United States (Recruiting)
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: William Obremskey, MD — Vanderbilt Medical Center
- Study coordinator: William Obremskey, MD
- Email: william.obremskey@vumc.org
- Phone: 615-260-2054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.