Back to resultsAntibiotic Prophylaxis in Open Fractures
Primary Purpose
Open Fractures
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ceftaroline
Sponsored by
About this trial
This is an interventional treatment trial for Open Fractures
Eligibility Criteria
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
Sites / Locations
- Triple O Research Institute PA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
open fractures type II and III
Arm Description
Every patients will receive Ceftaroline in an open label, single arm
Outcomes
Primary Outcome Measures
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
Secondary Outcome Measures
Incidence of acute kidney injury
Full Information
NCT ID
NCT02937181
First Posted
October 14, 2016
Last Updated
October 26, 2016
Sponsor
Olayemi Osiyemi MD
Collaborators
Forest Laboratories
1. Study Identification
Unique Protocol Identification Number
NCT02937181
Brief Title
Antibiotic Prophylaxis in Open Fractures
Official Title
Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olayemi Osiyemi MD
Collaborators
Forest Laboratories
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
open fractures type II and III
Arm Type
Experimental
Arm Description
Every patients will receive Ceftaroline in an open label, single arm
Intervention Type
Drug
Intervention Name(s)
Ceftaroline
Other Intervention Name(s)
Teflaro
Intervention Description
IV Ceftaroline will be given for 72 hours
Primary Outcome Measure Information:
Title
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence of acute kidney injury
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Identify bacteria associated with the infections
Time Frame
30 days
Title
identify the number of infections associated with sites other than fracture site
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Glickman
Phone
561-855-7871
Email
pglickman@tripleoresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Olayemi Osiyemi, MD
Phone
561-855-7871
Email
drtripleo@tripleoresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olayemi Osiyemi, MD
Organizational Affiliation
Triple O Research Institute PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Triple O Research Institute PA
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
no personal data, identifier and the data are made available
Learn more about this trial
Antibiotic Prophylaxis in Open Fractures
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