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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months following injury.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

Select...

I am 17 years old or younger.

Select...

My doctor plans to treat my fracture without surgery.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with an infection at the fracture site.

Secondary outcome measures

Drug adverse events

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor

194 Previous Clinical Trials

42,855 Total Patients Enrolled

Sivashanmugam Raju, MDPrincipal InvestigatorSt. Louis University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical experiment have an age restriction, and if so, what is the minimum?

"As specified in the trial's eligibility requirements, participants must be aged 0 through 17."

Answered by AI

What is the regulatory clearance for IV cefazolin administered in a single dose?

"Cefazolin's safety has been extensively tested, thus it gets a score of 3. This drug is approved for use and partaking in Phase 4 trials."

Answered by AI

Am I eligible to join this medical study?

"To be suitable for this investigation, applicants must possess fractures and lie between the ages of 0 to 17. Altogether, 800 individuals are being sought out by medical researchers."

Answered by AI

Is there any availability in this investigation for participants?

"According to clinicaltrials.gov, this trial is not currently taking on any new patients. The initial post date was September 11th 2023 and the last update occurred on the 20th of that same month. Although this study has ceased recruitment for now, more than a thousand other medical trials are still open for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Antibiotic Prophylaxis in Pediatric Open Fractures

Raju Sivashanmugam 2023. "Antibiotic Prophylaxis in Pediatric Open Fractures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06055712.

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