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

Study Overview
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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.

Official Title
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Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Due to Gram-Negative Rods

Conditions
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Gram-negative Bacteremia

Intervention / Treatment
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* Diagnostic Test: Accelerate Pheno
* Diagnostic Test: Standard of Care


Participation Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pheno<br> | Diagnostic Test: Accelerate Pheno<br>* 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.<br>|
| Active Comparator: Standard of Care<br> | Diagnostic Test: Standard of Care<br>* Standard blood culture work up as determined by the site's microbiology lab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Desirability of Outcome Ranking (DOOR) - composite outcome | The primary endpoint is the probability that a patient will have a better DOOR when the Accelerate PhenoTest™ BC kit is used on positive blood cultures due to gram-negative rods compared to the standard of care | 30 days |