Antibiotic Prophylaxis in Open Fractures

October 26, 2016 updated by: Olayemi Osiyemi MD

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • West Palm Beach, Florida, United States, 33401
        • Triple O Research Institute PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: open fractures type II and III
Every patients will receive Ceftaroline in an open label, single arm
Drug: Ceftaroline
IV Ceftaroline will be given for 72 hours
Other Names:
  • Teflaro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of fracture site infection at 30 days between ceftaroline and historical hospital rate
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of acute kidney injury
Time Frame: 30 days
30 days

Other Outcome Measures

Outcome Measure
Time Frame
Identify bacteria associated with the infections
Time Frame: 30 days
30 days
identify the number of infections associated with sites other than fracture site
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olayemi Osiyemi MD

Collaborators

Forest Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2018

Study Completion (ANTICIPATED)

March 1, 2019

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (ESTIMATE)

October 18, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEF-IT-40B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

no personal data, identifier and the data are made available

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Fractures

Clinical Trials on Ceftaroline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe