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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Burns
• Intervention / Treatment: Other: PCR test

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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center-Regional Burn Center
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Health System
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of PCR results with blood culture results	72 hours after positive blood culture results

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: American Burn Association
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Nam Tran, PhD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2010
• Primary Completion (Actual): September 29, 2019
• Study Completion (Actual): September 29, 2019

Study Registration Dates

• First Submitted: June 4, 2010
• First Submitted That Met QC Criteria: June 8, 2010
• First Posted (Estimated): June 9, 2010

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Infection; Sepsis; Burn
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Wounds and Injuries; Sepsis; Burns
• Other Study ID Numbers: ABA-MCTG-0002