Antibiotic Prophylaxis in Pediatric Open Fractures

Part of paid clinical trials in St Louis, Missouri.

Sponsor
St. Louis University
Study ID
NCT06055712
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Fractures, Open
  • Infections

Eligibility Criteria

Sex
ALL
Age
0 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Cefazolin — DRUG
    Intravenous dose(s).
  • Cephalexin — DRUG
    Five days oral.

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Oct 2025
Primary completion
Sep 30, 2033
Completion
Jan 31, 2034

Study Design

Enrollment
800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: One dose of IV cefazolin
    Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.
  • Active Comparator: 24 hours IV cefazolin
    Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).
  • Active Comparator: 24 hours IV cefazolin plus 5 days oral cephalexin
    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.

Primary Outcome Measure

Number of participants with an infection at the fracture site. [ Time Frame: Up to 3 months following injury. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Saint Louis UniversitySt LouisMissouri63110-

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By research site
Saint Louis University· St Louis, MO

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