Rapid Detection of Staphylococcus Aureus in Burn Patients (PCR-Staph)

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

U.S. Army Medical Research and Materiel Command

Information provided by (Responsible Party):

American Burn Association

ClinicalTrials.gov Identifier:

NCT01140269

First received: June 4, 2010

Last updated: January 14, 2015

Last verified: July 2013

History of Changes

Purpose

The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.

Condition	Intervention
Burns Sepsis	Other: PCR test


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients

Resource links provided by NLM:

MedlinePlus related topics: Burns Sepsis

Drug Information available for: Staphylococcus aureus

U.S. FDA Resources

Further study details as provided by American Burn Association:

Primary Outcome Measures:

Correlation of PCR results with blood culture results [ Time Frame: 72 hours after positive blood culture results ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of signs of infection [ Time Frame: 14 days after the administrationof anti-Staphylococcus therapy ] [ Designated as safety issue: No ]
Duration of antibiotic use [ Time Frame: 14 days after administration of antimicrobial therapy ] [ Designated as safety issue: No ]
Correlation of PCR result with mortality [ Time Frame: Day 28 of intensive care unit stay ] [ Designated as safety issue: No ]


Estimated Enrollment:	240
Study Start Date:	May 2010
Estimated Study Completion Date:	October 2016
Estimated Primary Completion Date:	October 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: No PCR testing Control patients will not have PCR testing. This group will have routine testing and treatment as defined by the standard of care.
Experimental: PCR testing PCR will be used in parallel with routine laboratory tests such as culture. Treatment for PCR results will be based on the standard of care. Treatment of the patient will be dependent on the physician's clinical judgment based on existing clinical information including PCR, microbiology, patient physical presentation, and other laboratory results.	Other: PCR test PCR samples will test for Staphylococcus aureus (including MRSA) from wound swab and positive blood culture samples to augment treatment decisions. Serial PCR testing will follow after positive results to catalog pathogen loads over the course of treatment in a blinded fashion.

Detailed Description:

Burn patients have lost their primary barrier to microorganism invasion and therefore are continually and chronically exposed to pathogens. Ninety-seven percent of patients with >20% total body surface area (TBSA) burns develop septicemia; predominantly involving gram positive cocci including MRSA and methicillin sensitive Staphylococcus aureus. Blood culture (BC) is the traditional detection method for septicemia. However, antibiotics and inadequate sample volumes can impair detection by BC and results can take 3-4 days.

Polymerase chain reaction (PCR) represents a potential adjunct to BC. Pathogens are detected in a growth-independent manner by targeting their genetic make-up. Quantitative determining of pathogen DNA using PCR could aid in determining antimicrobial drug therapy efficacy by providing results on the same testing day as opposed to 3-4 days with BC. PCR may also detect persistent infections during antimicrobial therapy when culture samples are inhibited.

The aims of this study are:(1)to correlate quantitative PCR results with that of the BC; (2) to test the clinical application of PCR results with clinical outcomes of treatment of presumptive diagnosis of staphylococcal sepsis.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

20% or > TBSA burns at hospital admission
will require BC during hospital stay
Patient/surrogate able to sign consent

Exclusion Criteria:

allergic to nafcillin, cefazolin, vancomycin, linezolid, and/or daptomycin
on antibiotic(s) prior to first BC

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01140269

Locations


United States, California
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, United States, 95817
United States, Florida
University of Miami Health System
Miami, Florida, United States, 33136
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45221
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104

Sponsors and Collaborators

American Burn Association

U.S. Army Medical Research and Materiel Command

Investigators


Principal Investigator:	Nam Tran, PhD	University of California, Davis

More Information


Responsible Party:	American Burn Association
ClinicalTrials.gov Identifier:	NCT01140269 History of Changes
Other Study ID Numbers:	ABA-MCTG-0002
Study First Received:	June 4, 2010
Last Updated:	January 14, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by American Burn Association:


Burn Sepsis Infection

Additional relevant MeSH terms:


Sepsis Burns Infection Systemic Inflammatory Response Syndrome	Inflammation Pathologic Processes Wounds and Injuries

ClinicalTrials.gov processed this record on September 23, 2016

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