Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Gram-Negative Rod Bacteremia

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2020-08-31

Brief Summary

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The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.

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Detailed Description

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Conditions

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Gram-negative Bacteremia

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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Pheno

Group Type ACTIVE_COMPARATOR

Accelerate Pheno

Intervention Type DIAGNOSTIC_TEST

The Accelerate Pheno™ system and PhenoTest™ BC Kit 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

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DIAGNOSTIC_TEST

Standard blood culture work up as determined by the site's microbiology lab.

Interventions

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Accelerate Pheno

The Accelerate Pheno™ system and PhenoTest™ BC Kit 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 blood culture work up as determined by the site's microbiology lab.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on Gram stain)
* Blood culture drawn in the Emergency Department (ED)

Exclusion Criteria

* Patients not admitted to hospital
* Patients discharged from hospital prior to blood culture positivity
* Only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
* Positive blood culture with GNR in the prior 7 days (if known at the time of randomization)
* Transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization)
* GNR plus gram-positive organism, gram-negative cocci, and/or yeast detected on blood culture Gram stain
* Deceased or palliative care at the time of randomization
* Patient who is moribund (does not survive the initial 72 hours after enrollment)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No