Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Burns
- Sponsor
- American Burn Association
- Enrollment
- 218
- Locations
- 4
- Primary Endpoint
- Correlation of PCR results with blood culture results
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Correlation of PCR results with blood culture results
Time Frame: 72 hours after positive blood culture results
Secondary Outcomes
- 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)