Comparing oral and intravenous antibiotics for treating infected nonunion of fractures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase III clinical trial aims to compare the effectiveness of oral antibiotics versus intravenous antibiotics in treating infected nonunion of fractures after surgical fixation. The study will enroll 250 patients aged 18 and older who have experienced an infected nonunion following internal fixation of a fracture. Participants will be randomly assigned to receive either oral antibiotics for six weeks or intravenous antibiotics for the same duration. The primary outcome will assess clinical effectiveness based on the number of secondary re-admissions and treatment failures within one year, alongside other metrics such as treatment compliance and hospitalization duration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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 and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.
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:

1. 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. Patients with a prior history of chronic infection at the index site before fracture fixation
6. Patients with pathological fractures from a neoplastic process
7. History of Paget's Disease
8. The patient, or a designated proxy, unwilling to provide consent
9. The patient must be available for follow-up for at least 12 months following infection treatment

Where it's running

• Indiana University
  Indianapolis, Indiana, United States Recruiting
• University of Maryland , MD Department of Orthopaedics
  Baltimore, Maryland, United States Recruiting
• Hennepin Health
  Minneapolis, Minnesota, United States Recruiting
• Wake Forest University Baptist Medical Center
  Winston-Salem, North Carolina, United States Recruiting
• Penn State University M.S. Hershey Medical Center
  Hershey, Pennsylvania, United States Recruiting
• Vanderbilt Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: William Obremskey, MD — Vanderbilt Medical Center
• Study coordinator: William Obremskey, MD
• Email: william.obremskey@vumc.org
• Phone: 615-260-2054

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.