Antibiotic Prophylaxis in Open Fractures

NCT ID: NCT02937181

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Open Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open fractures type II and III

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

Group Type EXPERIMENTAL

Ceftaroline

Intervention Type DRUG

IV Ceftaroline will be given for 72 hours

Interventions

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Ceftaroline

IV Ceftaroline will be given for 72 hours

Intervention Type DRUG

Other Intervention Names

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Teflaro

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Olayemi Osiyemi MD

OTHER

Sponsor Role lead

Responsible Party

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Olayemi Osiyemi MD

President/

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Olayemi Osiyemi, MD

Role: PRINCIPAL_INVESTIGATOR

Triple O Research Institute PA

Locations

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Triple O Research Institute PA

West Palm Beach, Florida, United States

Site Status

Countries

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United States

Central Contacts

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Paul Glickman

Role: CONTACT

Phone: 561-855-7871

Email: [email protected]

Olayemi Osiyemi, MD

Role: CONTACT

Phone: 561-855-7871

Email: [email protected]

Other Identifiers

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TEF-IT-40B

Identifier Type: -

Identifier Source: org_study_id