Rapid Detection of Staphylococcus Aureus in Burn Patients (PCR-Staph)

American Burn Association

Status: Completed

Conditions: Burns; Sepsis

Treatments: Other: PCR test

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01140269

ABA-MCTG-0002

Details and patient eligibility

About

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

Full 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.

Enrollment: 218 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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218 participants in 2 patient groups

No PCR testing

No Intervention group

Description:

Control patients will not have PCR testing. This group will have routine testing and treatment as defined by the standard of care.

PCR testing

Experimental group

Description:

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.

Treatment:

Other: PCR test