Antibiotic Prophylaxis in Open Fractures

Olayemi Osiyemi MD

Status and phase: Unknown; Phase 4

Conditions: Open Fractures

Treatments: Drug: Ceftaroline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02937181

TEF-IT-40B

Details and patient eligibility

About

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

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

open fractures type II and III

Experimental group

Description:

Every patients will receive Ceftaroline in an open label, single arm

Treatment:

Drug: Ceftaroline