Rapid Detection of Staphylococcus Aureus in Burn Patients (PCR-Staph)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
American Burn Association
ClinicalTrials.gov Identifier:
NCT01140269
First received: June 4, 2010
Last updated: July 16, 2013
Last verified: July 2013

June 4, 2010
July 16, 2013
May 2010
May 2014   (final data collection date for primary outcome measure)
Correlation of PCR results with blood culture results [ Time Frame: 72 hours after positive blood culture results ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01140269 on ClinicalTrials.gov Archive Site
  • Duration of signs of infection [ Time Frame: 14 days after the administrationof anti-Staphylococcus therapy ] [ Designated as safety issue: No ]
  • Duration of antibiotic use [ Time Frame: 14 days after administration of antimicrobial therapy ] [ Designated as safety issue: No ]
  • Correlation of PCR result with mortality [ Time Frame: Day 28 of intensive care unit stay ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rapid Detection of Staphylococcus Aureus in Burn Patients
Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Burns
  • Sepsis
Other: PCR 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.
  • 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.
  • 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.
    Intervention: Other: PCR test
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
240
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01140269
ABA-MCTG-0002
Yes
American Burn Association
American Burn Association
U.S. Army Medical Research and Materiel Command
Principal Investigator: Nam Tran, PhD University of California, Davis
American Burn Association
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP