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Clinical Trials/NCT01140269
NCT01140269
Completed
Not Applicable

Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients

American Burn Association4 sites in 1 country218 target enrollmentMay 30, 2010
ConditionsBurnsSepsis

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2010
End Date
September 29, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (4)

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