Rapid Detection of Staphylococcus Aureus in Burn Patients (PCR-Staph)
The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients|
- Correlation of PCR results with blood culture results [ Time Frame: 72 hours after positive blood culture results ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||October 2016|
|Estimated Primary Completion Date:||October 2016 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01140269
|United States, California|
|University of California Davis Medical Center-Regional Burn Center|
|Sacramento, California, United States, 95817|
|United States, Florida|
|University of Miami Health System|
|Miami, Florida, United States, 33136|
|United States, Ohio|
|University of Cincinnati Medical Center|
|Cincinnati, Ohio, United States, 45221|
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98104|
|Principal Investigator:||Nam Tran, PhD||University of California, Davis|