Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

774 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2023-06-30

Brief Summary

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This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Patients will be randomized to one of the following FDA-cleared devices that will be used to assess the workflow impact of fast identification (ID) and antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients: 1) Standard culture and AST of positive blood culture bottles plus the Verigene® Blood Culture Gram-positive/Gram-negative kit (BC-GP/GN); or 2) Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System.

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Detailed Description

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Conditions

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Bloodstream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Accelerate Pheno

Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System

Group Type ACTIVE_COMPARATOR

Accelerate PhenoTest™ BC kit

Intervention Type DIAGNOSTIC_TEST

The Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System is a fully-integrated in vitro diagnostic system. It is FDA-cleared to perform ID of bacteria and yeast in less than 90 minutes and AST in less than 7 hours, on average, directly from positive blood culture

Standard of Care

Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DIAGNOSTIC_TEST

Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN

Interventions

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Accelerate PhenoTest™ BC kit

The Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System is a fully-integrated in vitro diagnostic system. It is FDA-cleared to perform ID of bacteria and yeast in less than 90 minutes and AST in less than 7 hours, on average, directly from positive blood culture

Intervention Type DIAGNOSTIC_TEST

Standard of Care

Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Verigene® BC-GP/GN

Eligibility Criteria

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Inclusion Criteria

* All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours
* All adult (≥18 years of age)

Exclusion Criteria

* Identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
* Positive blood culture in the prior week with same Gram stain result
* Transferred from an outside hospital and had a history of a previously positive blood culture of the same Gram stain result
* Previously enrolled in the study
* Only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
* Died or were transitioned to comfort care within 24 hours of enrollment
* Negative Gram-stain
* Not admitted to hospital for ≥ 24 hours following blood culture positivity

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No