PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation
Recruiting
Phase 3
Interventional Study
Infections
Infected Wound
Nonunion of Fracture
Injury Leg
Amputation
Internal Fixation; Complications, Infection or Inflammation
Fracture
Lower Extremity Fracture
Antibiotic Side Effect
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 250 (estimated)
- Sponsor
- Major Extremity Trauma Research Consortium · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 treatmen…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
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 …
Contacts