Antibiotic Prophylaxis in Open Fractures
Antibiotic Prophylaxis With Ceftaroline for Type II and II Open Fractures: a Phase 4, Open-label, Prospective Clinical Trial
1 other identifier
interventional
50
1 country
1
Brief Summary
Prospective look at antibiotic prophylaxis with Ceftaroline in patients with type II and III open fractures
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2016
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2016
CompletedFirst Posted
Study publicly available on registry
October 18, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedOctober 28, 2016
October 1, 2016
1.8 years
October 14, 2016
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
30 days
Secondary Outcomes (1)
Incidence of acute kidney injury
30 days
Other Outcomes (2)
Identify bacteria associated with the infections
30 days
identify the number of infections associated with sites other than fracture site
30 days
Study Arms (1)
open fractures type II and III
EXPERIMENTALEvery patients will receive Ceftaroline in an open label, single arm
Interventions
IV Ceftaroline will be given for 72 hours
Eligibility Criteria
You may qualify if:
- male or female \>= 18 years old
- complete an informed consent
- patients are diagnosed with a type II or III open fracture
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Olayemi Osiyemi MDlead
- Forest Laboratoriescollaborator
Study Sites (1)
Triple O Research Institute PA
West Palm Beach, Florida, 33401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olayemi Osiyemi, MD
Triple O Research Institute PA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- President/
Study Record Dates
First Submitted
October 14, 2016
First Posted
October 18, 2016
Study Start
December 1, 2016
Primary Completion
October 1, 2018
Study Completion
March 1, 2019
Last Updated
October 28, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
no personal data, identifier and the data are made available