PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation (NCT05699174)
PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Indiana University — Indianapolis, Indiana
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Indiana University — Indianapolis, Indiana
- University of Maryland , MD Department of Orthopaedics — Baltimore, Maryland
- Sinai Hospital Baltimore — Baltimore, Maryland
- Hennepin Health — Minneapolis, Minnesota
- Jamaica Hospital Medical Center — Queens, New York
- Atrium Health, Carolinas Medical Center — Charlotte, North Carolina
- Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina
- University of Okalahoma College of Medicine — Oklahoma City, Oklahoma
- Penn State University M.S. Hershey Medical Center — Hershey, Pennsylvania
- Vanderbilt Medical Center — Nashville, Tennessee
- University of Texas Health Science Center at Houston — Houston, Texas
- University of Washington Harborview Medical Center — Seattle, Washington
- University of Wisconsin — Madison, Wisconsin
📞 Contact the Study Coordinator
Phone: (615) 260-2054
Email: william.obremskey@vumc.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.