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

Primary Purpose

Burns, Sepsis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PCR test
Sponsored by
American Burn Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Burns focused on measuring Burn, Sepsis, Infection

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis Medical Center-Regional Burn Center
  • University of Miami Health System
  • University of Cincinnati Medical Center
  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No PCR testing

PCR testing

Arm Description

Control patients will not have PCR testing. This group will have routine testing and treatment as defined by the standard of care.

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.

Outcomes

Primary Outcome Measures

Correlation of PCR results with blood culture results

Secondary Outcome Measures

Duration of signs of infection
Duration of antibiotic use
Correlation of PCR result with mortality

Full Information

First Posted
June 4, 2010
Last Updated
August 2, 2023
Sponsor
American Burn Association
Collaborators
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01140269
Brief Title
Rapid Detection of Staphylococcus Aureus in Burn Patients
Acronym
PCR-Staph
Official Title
Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2010 (Actual)
Primary Completion Date
September 29, 2019 (Actual)
Study Completion Date
September 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Burn Association
Collaborators
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Sepsis
Keywords
Burn, Sepsis, Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No PCR testing
Arm Type
No Intervention
Arm Description
Control patients will not have PCR testing. This group will have routine testing and treatment as defined by the standard of care.
Arm Title
PCR testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
PCR test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation of PCR results with blood culture results
Time Frame
72 hours after positive blood culture results
Secondary Outcome Measure Information:
Title
Duration of signs of infection
Time Frame
14 days after the administrationof anti-Staphylococcus therapy
Title
Duration of antibiotic use
Time Frame
14 days after administration of antimicrobial therapy
Title
Correlation of PCR result with mortality
Time Frame
Day 28 of intensive care unit stay

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nam Tran, PhD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis Medical Center-Regional Burn Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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Rapid Detection of Staphylococcus Aureus in Burn Patients

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