Antibiotic Prophylaxis in Pediatric Open Fractures

NCT06055712 | Enrolling By Invitation Phase 4 DMC FDA Drug

• 1 other identifier: 30873
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fractures, Open; Infections

Keywords

Pediatric open fracture; Antibiotic regimen; Infection rate

Outcome Measures

Primary Outcomes (1)

• Number of participants with an infection at the fracture site.

  Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.

  Up to 3 months following injury.

Secondary Outcomes (1)

• Drug adverse events

  Up to 3 months following injury.

Study Arms (3)

One dose of IV cefazolin

ACTIVE COMPARATOR

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

Drug: Cefazolin

24 hours IV cefazolin

ACTIVE COMPARATOR

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

Drug: Cefazolin

24 hours IV cefazolin plus 5 days oral cephalexin

ACTIVE COMPARATOR

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.

Drug: Cefazolin; Drug: Cephalexin

Interventions

Cefazolin DRUG

Intravenous dose(s).

24 hours IV cefazolin; 24 hours IV cefazolin plus 5 days oral cephalexin; One dose of IV cefazolin

Cephalexin DRUG

Five days oral.

24 hours IV cefazolin plus 5 days oral cephalexin

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients ages 0-17 years old
• Skeletally immature patients, as confirmed by xray imaging evaluated by an orthopaedic surgeon
• Patient as sustained a grade 1 or 2 open fracture within 24 hours of presentation
• Physician plans to manage the fracture non-operatively

You may not qualify if:

• Patients 18 years or older
• Skeletally mature patients, as as confirmed by xray imaging evaluated by an orthopaedic surgeon
• Patients with grade 3 open fractures
• Gross contamination of the fracture
• Fracture requires surgery
• Immunocompromised patients
• Allergies to cephalosporins
• Severe penicillin allergy
• non-English speaking patients \&/or guardian

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

Saint Louis University

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Fractures, Open; Infections

Interventions

Cefazolin; Cephalexin

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sivashanmugam Raju, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: September 11, 2023
• Primary Completion (Estimated): September 1, 2033
• Study Completion (Estimated): January 1, 2034
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)