Antibiotic Prophylaxis in Open Fractures | NCT02937181

Studies
Antibiotic Prophylaxis in Open Fractures

NCT02937181

Sponsor

Olayemi Osiyemi MD

Status

Unknown status

Last Update Posted

Oct 28, 2016Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Open Fractures

Interventions

Ceftaroline

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016

Primary Completion Date

Oct 2018Estimated

Completion Date

Mar 2019Estimated

First Submitted Date

Oct 14, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Name	Class
Forest Laboratories	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
open fractures type II and III	Experimental	Every patients will receive Ceftaroline in an open label, single arm	Drug: Ceftaroline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftaroline	Drug	IV Ceftaroline will be given for 72 hours	open fractures type II and III

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Incidence of acute kidney injury		30 days

Other Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Paul Glickman	Contact	561-855-7871		pglickman@tripleoresearch.com
Olayemi Osiyemi, MD	Contact	561-855-7871		drtripleo@tripleoresearch.com

Overall Officials

Name	Affiliation	Role
Olayemi Osiyemi, MD	Triple O Research Institute PA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Triple O Research Institute PA		West Palm Beach	Florida	33401	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

no personal data, identifier and the data are made available

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005597	Fractures, Open

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000097583	Ceftaroline

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided