Rapid Detection of Staphylococcus Aureus in Burn Patients (PCR-Staph)
|ClinicalTrials.gov Identifier: NCT01140269|
Recruitment Status : Active, not recruiting
First Posted : June 9, 2010
Last Update Posted : December 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Burns Sepsis||Other: PCR test||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients|
|Study Start Date :||May 2010|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
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.
- Correlation of PCR results with blood culture results [ Time Frame: 72 hours after positive blood culture results ]
- Duration of signs of infection [ Time Frame: 14 days after the administrationof anti-Staphylococcus therapy ]
- Duration of antibiotic use [ Time Frame: 14 days after administration of antimicrobial therapy ]
- Correlation of PCR result with mortality [ Time Frame: Day 28 of intensive care unit stay ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|