Burns, Sepsis
Conditions
Keywords
Burn, Sepsis, Infection
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.
Interventions
OTHERPCR 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.
Sponsors
U.S. Army Medical Research and Development Command
American Burn Association
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation of PCR results with blood culture results | 72 hours after positive blood culture results |
Secondary
| Measure | Time frame |
|---|---|
| Duration of signs of infection | 14 days after the administrationof anti-Staphylococcus therapy |
| Duration of antibiotic use | 14 days after administration of antimicrobial therapy |
| Correlation of PCR result with mortality | Day 28 of intensive care unit stay |
Countries
United States
Outcome results
None listed