Antibiotics for Pediatric Broken Bones
What You Need to Know Before You Apply
What is the purpose of this trial?
This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is cephalexin safe for use in humans?
How is the drug Cefazolin and Cephalexin unique for treating pediatric broken bones?
What evidence supports the effectiveness of the drug for treating pediatric broken bones?
Who Is on the Research Team?
Sivashanmugam Raju, MD
Principal Investigator
St. Louis University
Are You a Good Fit for This Trial?
This trial is for children and teens (0-17 years old) with immature bones who have a mild to moderate open fracture that happened within the last day. They must be able to take cephalosporin antibiotics, not need surgery for the fracture, and speak English.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive antibiotic treatment based on randomization: one dose of IV cefazolin, 24 hours of IV cefazolin, or 24 hours of IV cefazolin plus 5 days of oral cephalexin
Follow-up
Participants are monitored for infection and adverse events at follow-up appointments or through phone contact
Extended Follow-up
Study team members check medical records for infection or adverse events, and conduct phone interviews if no follow-up is reported
What Are the Treatments Tested in This Trial?
Interventions
- Cefazolin
- Cephalexin
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Louis University
Lead Sponsor