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NCT05699174 · ClinicalTrials.gov registry record · Phase 3
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
A Phase 3 study of Amputation and Infections, sponsored by Major Extremity Trauma Research Consortium.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
- 13
- Study locations
NCT05699174: Recruiting Phase 3 study of Amputation and Infections, sponsored by Major Extremity Trauma Research Consortium.
NCT05699174 is a Phase 3 study of Amputation and Infections that is actively recruiting participants, run by Major Extremity Trauma Research Consortium. The registered enrollment target is 250 participants, above the 129-participant average among 65 other Amputation trials with a reported enrollment target (94% higher). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05699174, a Phase 3 study of Amputation and Infections, is actively recruiting participants, sponsored by Major Extremity Trauma Research Consortium.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
- 13
- Study locations
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.
Primary Outcome
Total number of re-admissions after revision fixation over the first 365 days post discharge from the hospitalization for initial surgical treatment of the infected nonunion. Re-admission can be for infection, nonunion, soft tissue revision, line complication, or antibiotic complication.
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 |
What NCT05699174 shows while recruiting
NCT05699174 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 129-participant average among 65 other Amputation trials with a reported enrollment target (94% higher).
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.
NCT05699174 lists 13 locations in 11 states (Maryland, North Carolina, Indiana).
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.
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).
Who is sponsoring clinical trial NCT05699174?
This trial is sponsored by Major Extremity Trauma Research Consortium, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05699174's enrollment target sits among peer trials
250 6th of 65 higher than 60 of 65 other Amputation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amputation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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