Antibiotics for Pediatric Broken Bones

Recruiting in Palo Alto (17 mi)

Overseen bySivashanmugam Raju, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: St. Louis University

No Placebo Group

Prior Safety Data

Trial Summary

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.

Research Team

Sivashanmugam Raju, MD

Principal Investigator

St. Louis University

Eligibility Criteria

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

I have a minor to moderate open fracture that occurred within the last day.

Patients under 18 years of age, as determined by radiologic imaging assessed by an orthopaedic doctor.

I am 17 years old or younger.

See 1 more

Exclusion Criteria

Allergies to cephalosporins

I am 18 years old or older.

You have a severe allergic reaction to penicillin.

See 6 more

Treatment Details

Interventions

Cefazolin (Anti-tumor antibiotic)
Cephalexin (Anti-tumor antibiotic)

Trial OverviewThe study compares infection rates in young patients with open fractures using different antibiotic treatments: one dose of IV cefazolin, 24 hours of IV cefazolin, or 24 hours of IV cefazolin plus 5 days oral cephalexin.

Participant Groups

3Treatment groups

Active Control

Group I: One dose of IV cefazolinActive Control1 Intervention

Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.

Group II: 24 hours IV cefazolinActive Control1 Intervention

Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).

Group III: 24 hours IV cefazolin plus 5 days oral cephalexinActive Control2 Interventions

Patients in group C will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Additionally, they will be instructed to take 5 days of oral cephalexin.