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PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
NCT05699174 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Standard of Care PO (oral) antibiotics
- DRUG Standard of Care Intravenous (IV) antibiotics
Study Locations (13)
Maryland
- University of Maryland , MD Department of Orthopaedics — Baltimore
- Sinai Hospital Baltimore — Baltimore
North Carolina
- Atrium Health, Carolinas Medical Center — Charlotte
- Wake Forest University Baptist Medical Center — Winston-Salem
Indiana
- Indiana University — Indianapolis
Minnesota
- Hennepin Health — Minneapolis
New York
- Jamaica Hospital Medical Center — Queens
Oklahoma
- University of Okalahoma College of Medicine — Oklahoma City
Pennsylvania
- Penn State University M.S. Hershey Medical Center — Hershey
Tennessee
- Vanderbilt Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2023-05-30 |
| Est. Completion | 2027-09-29 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05699174
The ClinicalTrials.gov registry entry for NCT05699174 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Major Extremity Trauma Research Consortium, which has 71 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 9 conditions, with Amputation appearing as the primary indexed condition, and to 2 interventions — of which Standard of Care PO (oral) antibiotics is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05699174 reports 13 study locations spanning 11 distinct geographic areas — top geographies include Maryland, North Carolina, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05699174 about?
NCT05699174 is a clinical study titled "PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation". 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 ...
What is the current status of trial NCT05699174?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2023-05-30. Estimated completion is 2027-09-29.
What conditions does trial NCT05699174 study?
This clinical trial studies the following conditions: Amputation, Infections, Fracture, Lower Extremity Fracture, Nonunion of Fracture. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05699174?
The interventions under investigation include: Standard of Care PO (oral) antibiotics (DRUG), Standard of Care Intravenous (IV) antibiotics (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05699174?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 71 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05699174 being conducted?
This trial has 13 study locations across Indiana, Maryland, Minnesota, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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