The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
218
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.
University of California Davis Medical Center-Regional Burn Center
Sacramento, California, United States
University of Miami Health System
Miami, Florida, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Harborview Medical Center
Seattle, Washington, United States
Correlation of PCR results with blood culture results
Time frame: 72 hours after positive blood culture results
Duration of signs of infection
Time frame: 14 days after the administrationof anti-Staphylococcus therapy
Duration of antibiotic use
Time frame: 14 days after administration of antimicrobial therapy
Correlation of PCR result with mortality
Time frame: Day 28 of intensive care unit stay
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