Rapid Detection of Staphylococcus Aureus in Burn Patients

Not Applicable

Completed

• Conditions: Burns; Sepsis
• Interventions: Other: PCR test

• Registration Number: NCT01140269
• Lead Sponsor: American Burn Association

Brief Summary

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

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 Timeline

• Study Start: 2010-05-30
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-08
• Study First Posted: 2010-06-09
• Primary Completion: 2019-09-29
• Study Completion: 2019-09-29
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PCR testing	PCR test	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.

Primary Outcome Measures

Name	Time	Method
Correlation of PCR results with blood culture results	72 hours after positive blood culture results

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

University of Miami Health System; 🇺🇸 Miami, Florida, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of California Davis Medical Center-Regional Burn Center; 🇺🇸 Sacramento, California, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States