NCT05699174 · Major Extremity Trauma Research Consortium
PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
(POvIV2)
What this study is about
This is a Phase III clinical randomly assigned 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.
View original scientific description
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.
Interventions
DRUG
Standard of Care PO (oral) antibiotics
An intervention in this study includes randomization of patients with an infected nonunion to PO (oral) antibiotics for up to 6 weeks post hospitalization. The exact type of oral antibiotic will be depended on the patient's infection diagnosis.
DRUG
Standard of Care Intravenous (IV) antibiotics
An intervention in this study includes randomization of patients with an infected nonunion to intravenous (IV) antibiotics for up to 6 weeks post hospitalization. The exact type of IV antibiotic will be depended on the patient's infection diagnosis.
Primary outcome measures
Number of patients with a hospital re-admission
Time frame: 1 year
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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. Pa
Where
- Indianapolis, Indiana
- Baltimore, Maryland
- Minneapolis, Minnesota
- Queens, New York
- Charlotte, North Carolina
- Winston-Salem, North Carolina
- Oklahoma City, Oklahoma
- Hershey, Pennsylvania
- Nashville, Tennessee
- Houston, Texas
- Seattle, Washington
- Madison, Wisconsin
Collaborators
United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations