Antibiotic Prophylaxis in Open Fractures

Open Fractures Clinical Trial

Official title:

Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02937181
• Other study ID #: TEF-IT-40B
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 14, 2016
• Last updated: October 26, 2016
• Start date: December 2016
• Est. completion date: March 2019

Study information

• Verified date: October 2016
• Source: Triple O Research Institute PA
• Contact: Paul Glickman
• Phone: 561-855-7871
• Email: pglickman[@]tripleoresearch.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Fractures, Open
• Open Fractures

Intervention

Drug:
• Ceftaroline
IV Ceftaroline will be given for 72 hours

Locations

Country	Name	City	State
United States	Triple O Research Institute PA	West Palm Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Olayemi Osiyemi MD	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Identify bacteria associated with the infections		30 days	Yes
Other	identify the number of infections associated with sites other than fracture site		30 days	Yes
Primary	Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate		30 days	No
Secondary	Incidence of acute kidney injury		30 days	Yes