Antibiotic Prophylaxis in Open Fractures

Phase 4

• Conditions: Open Fractures
• Interventions: Drug: Ceftaroline

• Registration Number: NCT02937181
• Lead Sponsor: Olayemi Osiyemi MD

Brief Summary

Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures

Detailed Description

Determine if antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures is a safe and effective alternative to standard combination therapy

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28
• Study Start: 2016-12
• Primary Completion: 2018-10
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• male or female >= 18 years old
• complete an informed consent
• patients are diagnosed with a type II or III open fracture

Exclusion Criteria

• allergy to beta-lactam antibiotics prior to screening
• prior to enrollment: patients received 3 or more doses of antibiotic prophylaxis
• pregnant female
• inability to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open fractures type II and III	Ceftaroline	Every patients will receive Ceftaroline in an open label, single arm

Primary Outcome Measures

Name	Time	Method
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate	30 days

Secondary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury	30 days

Trial Locations

Locations (1)

Triple O Research Institute PA; 🇺🇸 West Palm Beach, Florida, United States