Rapid Detection of Staphylococcus Aureus in Burn Patients

NCT ID: NCT01140269

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-30
• Study Completion Date: 2019-09-29

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.

Conditions

Burns; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

PCR test

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

American Burn Association

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nam Tran, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California Davis Medical Center-Regional Burn Center

Sacramento, California, United States

University of Miami Health System

Miami, Florida, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

ABA-MCTG-0002

Identifier Type: -

Identifier Source: org_study_id