BridgeMD
Compares treatment options for Infections
Official title PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
ClinicalTrials.gov ID: NCT05699174
What this study is testing
- What it's testing
- This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius...
- Infection as determined by either
- FRI criteria
- CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon
- Systemic antibiotic treatment regimen scheduled for at least 6 weeks
You likely can't join if
- Patients with a high risk of amputation based on the initial managing physician
- Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months...
- Incarcerated or institutionalized patients
- Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic
- Patients with a prior history of chronic infection at the index site before fracture fixation
- Patients with pathological fractures from a neoplastic process
See the full eligibility criteria
- 1\. Bone fracture (proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation...
- Infection as determined by either
- FRI criteria
- CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon
- Systemic antibiotic treatment regimen scheduled for at least 6 weeks
- Patients with a high risk of amputation based on the initial managing physician
- Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment
- Incarcerated or institutionalized patients
- Patients who are unable to return for required follow-up visits and/or medical co-morbidities which preclude treatment with a general anesthetic
- Patients with a prior history of chronic infection at the index site before fracture fixation
- Patients with pathological fractures from a neoplastic process
- History of Paget's Disease
- The patient, or a designated proxy, unwilling to provide consent
- The patient must be available for follow-up for at least 12 months following infection treatment
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- Queens, New York, United States
- Charlotte, North Carolina, United States
- Winston-Salem, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Hershey, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Seattle, Washington, United States
- Madison, Wisconsin, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Baltimore, Maryland, United States; Minneapolis, Minnesota, United States; Queens, New York, United States; Charlotte, North Carolina, United States; Winston-Salem, North Carolina, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.