Antimicrobial Resistance of Bacteria in Burn Patients | NCT00794742

Studies
Antimicrobial Resistance of Bacteria in Burn Patients

NCT00794742

Sponsor

Texas Tech University Health Sciences Center

Status

Completed

Last Update Posted

Apr 13, 2015Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Burns

Interventions

Not provided

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

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Nov 19, 2008

First Submission Date that Met QC Criteria

Nov 19, 2008

First Posted Date

Nov 20, 2008Estimated

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

Apr 9, 2015

Last Update Posted Date

Apr 13, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to test the resistance of pathogenic bacteria in infected tissues of burn patients to various antimicrobials and enzyme debriders.

Detailed Description

Bacteria that is present in infected burn wounds will be isolated and identified. The isolates will be tested for resistance to commercially available antimicrobials.

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

32Actual

Label	Type	Description	Intervention Names
Burn Wounds		Patients with burn wounds

Measure	Description	Time Frame
Types of bacteria		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females of any age
Have open, unhealed wounds(s) that will be cultured per standard of care
Subject or authorized representative provide informed consent

Exclusion Criteria:

Informed consent not provided or able to be obtained

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with open,unhealed,burn wounds

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Griswold, M.D.	Texas Tech University Health Sciences Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center		Lubbock	Texas	79415	United States