NCT05699174 PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
| NCT ID | NCT05699174 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Major Extremity Trauma Research Consortium |
| Condition | Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-05-30 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 250 participants in total. It began in 2023-05-30 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
William Obremskey, MD
PRINCIPAL INVESTIGATOR
Vanderbilt Medical Center
Frequently Asked Questions
Who can join the NCT05699174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05699174 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 250 participants.
Is NCT05699174 currently recruiting?
Yes, NCT05699174 is actively recruiting participants. Contact the research team at william.obremskey@vumc.org for enrollment information.
Where is the NCT05699174 trial being conducted?
This trial is being conducted at Indianapolis, United States, Baltimore, United States, Baltimore, United States, Minneapolis, United States and 9 additional locations.
Who is sponsoring the NCT05699174 clinical trial?
NCT05699174 is sponsored by Major Extremity Trauma Research Consortium. The principal investigator is William Obremskey, MD at Vanderbilt Medical Center. The trial plans to enroll 250 participants.