Clinical trial NCT01140269: Rapid Detection of Staphylococcus Aureus in Burn Patients
Official title: Rapid, Quantitative, PCR-Based Detection Of Staphylococcus Aureus in Burn Sepsis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Sepsis
Keywords: Burn
Sepsis
Infection
Lead sponsor: American Burn Association
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2010-06-09
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Correlation of PCR results with blood culture results
timeFrame: 72 hours after positive blood culture results
Secondary outcomes:
measure: Duration of signs of infection
timeFrame: 14 days after the administrationof anti-Staphylococcus therapy
measure: Duration of antibiotic use
timeFrame: 14 days after administration of antimicrobial therapy
measure: Correlation of PCR result with mortality
timeFrame: Day 28 of intensive care unit stay
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center-Regional Burn Center
state: California
city: Miami
country: United States
facility: University of Miami Health System
state: Florida
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of California, Davis
name: Nam Tran, PhD
role: PRINCIPAL_INVESTIGATOR
References: