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OpenTrials
Completed

NCT Number: NCT01140269

Rapid Detection of Staphylococcus Aureus in Burn Patients

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PCR test

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.

Primary outcomes

  1. Correlation of PCR results with blood culture results

    Time frame: 72 hours after positive blood culture results

Secondary outcomes

  1. Duration of signs of infection

    Time frame: 14 days after the administrationof anti-Staphylococcus therapy

  2. Duration of antibiotic use

    Time frame: 14 days after administration of antimicrobial therapy

  3. Correlation of PCR result with mortality

    Time frame: Day 28 of intensive care unit stay

Sponsors and collaborators

Lead sponsor

American Burn Association

Other

Collaborators

  • U.S. Army Medical Research and Development Command

Registry information

Official study title

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

Acronym: PCR-Staph

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
Jun 9, 2010
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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