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Anti-tumor antibiotic

Antibiotics for Pediatric Broken Bones

Phase 4

Waitlist Available

Led By Sivashanmugam Raju, MD

Research Sponsored by St. Louis University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient as sustained a grade 1 or 2 open fracture within 24 hours of presentation

Pediatric patients ages 0-17 years old

Must not have

Patients with grade 3 open fractures

Fracture requires surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months following injury.

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study infection rates in children with open fractures. 3 different treatments will be used.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects from the antibiotics may include allergic reactions, stomach upset like diarrhea or nausea, rash, and less commonly blood disorders or severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 17 years old or younger.

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My doctor plans to treat my fracture without surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a severe open fracture.

Select...

I need surgery for my fracture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months following injury.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months following injury.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months following injury. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with an infection at the fracture site.

Secondary study objectives

Drug adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 5Eligibility criteria met