PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Public ClinicalTrials.gov record NCT05699174. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05699174
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Interventions
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 29, 2023
- Primary completion
- Aug 31, 2027
- Completion
- Sep 28, 2028
- Last update posted
- Jun 10, 2026
2023 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | Recruiting |
| University of Maryland , MD Department of Orthopaedics | Baltimore | Maryland | 21201 | Recruiting |
| Sinai Hospital Baltimore | Baltimore | Maryland | 21215 | Not yet recruiting |
| Hennepin Health | Minneapolis | Minnesota | 55487 | Recruiting |
| Jamaica Hospital Medical Center | Queens | New York | 11418 | Not yet recruiting |
| Atrium Health, Carolinas Medical Center | Charlotte | North Carolina | 28207 | Not yet recruiting |
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27106 | Recruiting |
| University of Okalahoma College of Medicine | Oklahoma City | Oklahoma | 73104 | Not yet recruiting |
| Penn State University M.S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | Recruiting |
| Vanderbilt Medical Center | Nashville | Tennessee | 37203 | Recruiting |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | Not yet recruiting |
| University of Washington Harborview Medical Center | Seattle | Washington | 98195 | Recruiting |
| University of Wisconsin | Madison | Wisconsin | 53705 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05699174, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 10, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05699174 live on ClinicalTrials.gov.