Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

743 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to increased cost)?

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Detailed Description

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We hypothesize that the FilmArray Blood Culture ID Panel will reduce the duration of empiric broad-spectrum antimicrobial therapy typically administered in patients who have positive blood cultures, improving clinical outcome and reducing cost. To test this hypothesis we propose a prospective, randomized controlled study comparing outcomes among patients with positive blood cultures who receive either: Standard culture and antimicrobial susceptibility testing (AST) of positive blood culture bottles as is done today (control), standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel (intervention group 1), or standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel testing along with expert infectious diseases phone consultation (intervention group 2). In both intervention groups, results of the FilmArray test will be communicated by phone to the primary service, along with templated comments about optimal antimicrobial therapy, based on the result. (Templated comments will also be used in the control group). In intervention group 2, an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy, if appropriate, based on microbiology results and clinical information obtained through medical record review and discussion with the primary service.

Conditions

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Bacteremia Fungemia Bloodstream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Control

Standard Mayo practices (bacterial culture and susceptibility testing) will be used. FilmArray testing will not be performed.

Group Type EXPERIMENTAL

Bacterial culture

Intervention Type OTHER

This test identifies the pathogen responsible for an infection.

Susceptibility testing

Intervention Type OTHER

Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics. Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics.

FilmArray test

Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.

Group Type EXPERIMENTAL

FilmArray testing

Intervention Type DEVICE

FilmArray Blood Culture Identification (BCID) Panel is a polymerase chain reaction (PCR) panel that identifies 19 types of bacteria, 5 types of fungi, and select antimicrobial-resistance genes.

Bacterial culture

Intervention Type OTHER

This test identifies the pathogen responsible for an infection.

Susceptibility testing

Intervention Type OTHER

Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics. Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics.

FilmArray plus antimicrobial stewardship

Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.

Group Type EXPERIMENTAL

FilmArray testing

Intervention Type DEVICE

FilmArray Blood Culture Identification (BCID) Panel is a polymerase chain reaction (PCR) panel that identifies 19 types of bacteria, 5 types of fungi, and select antimicrobial-resistance genes.

Antimicrobial Stewardship

Intervention Type BEHAVIORAL

Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.

Bacterial culture

Intervention Type OTHER

This test identifies the pathogen responsible for an infection.

Susceptibility testing

Intervention Type OTHER

Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics. Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics.

Interventions

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FilmArray testing

FilmArray Blood Culture Identification (BCID) Panel is a polymerase chain reaction (PCR) panel that identifies 19 types of bacteria, 5 types of fungi, and select antimicrobial-resistance genes.

Intervention Type DEVICE

Antimicrobial Stewardship

Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.

Intervention Type BEHAVIORAL

Bacterial culture

This test identifies the pathogen responsible for an infection.

Intervention Type OTHER

Susceptibility testing

Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics. Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics.

Intervention Type OTHER

Other Intervention Names

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FilmArray Blood Culture Identification Panel

Eligibility Criteria

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Inclusion Criteria

* Positive blood culture during the study period.
* No positive blood cultures in prior 7 days
* Minnesota state research authorization provided

Exclusion Criteria

* No Minnesota state research authorization
* Deceased or transitioned to comfort care within 24 hours of enrollment
* Positive blood culture in prior 7 days
* Previously enrolled in this study
* Negative Gram stain

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No