Rapid Detection of Staphylococcus Aureus in Burn Patients (PCR-Staph)
Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Sacramento, California, United States, 95817
- University of California Davis Medical Center-Regional Burn Center
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Florida
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Miami, Florida, United States, 33136
- University of Miami Health System
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Ohio
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Cincinnati, Ohio, United States, 45221
- University of Cincinnati Medical Center
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Washington
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Seattle, Washington, United States, 98104
- Harborview Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Correlation of PCR results with blood culture results
Time Frame: 72 hours after positive blood culture results
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72 hours after positive blood culture results
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Duration of signs of infection
Time Frame: 14 days after the administrationof anti-Staphylococcus therapy
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14 days after the administrationof anti-Staphylococcus therapy
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Duration of antibiotic use
Time Frame: 14 days after administration of antimicrobial therapy
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14 days after administration of antimicrobial therapy
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Correlation of PCR result with mortality
Time Frame: Day 28 of intensive care unit stay
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Day 28 of intensive care unit stay
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nam Tran, PhD, University of California, Davis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABA-MCTG-0002
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