Rapid Detection of Staphylococcus Aureus in Burn Patients

Sepsis Clinical Trial

— PCR-Staph  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01140269
• Other study ID #: ABA-MCTG-0002
• Status: Completed
• Phase: N/A
• Start date: May 30, 2010
• Est. completion date: September 29, 2019

Study information

• Verified date: August 2023
• Source: American Burn Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if rapid early detection of the bacteria causing sepsis in burn patients improves patient outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: September 29, 2019
• Est. primary completion date: September 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Sepsis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	University of Miami Health System	Miami	Florida
United States	University of California Davis Medical Center-Regional Burn Center	Sacramento	California
United States	Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
American Burn Association	U.S. Army Medical Research and Development Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of PCR results with blood culture results		72 hours after positive blood culture results
Secondary	Duration of signs of infection		14 days after the administrationof anti-Staphylococcus therapy
Secondary	Duration of antibiotic use		14 days after administration of antimicrobial therapy
Secondary	Correlation of PCR result with mortality		Day 28 of intensive care unit stay