Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Study Overview
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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.

Official Title
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Randomized Trial of Fast Bacterial Identification and Phenotypic Antimicrobial Susceptibility Testing in Patients With Positive Blood Cultures Using the Accelerate PhenoTest™ BC Kit, Performed on the Accelerate Pheno™ System as Compared With the Verigene® BC-GP/GN

Conditions
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Bloodstream Infection

Intervention / Treatment
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* Diagnostic Test: Accelerate PhenoTest™ BC kit
* Diagnostic Test: Standard of Care


Participation Criteria
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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

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: Accelerate Pheno<br>Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System | Diagnostic Test: Accelerate PhenoTest™ BC kit<br>* 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<br>|
| Active Comparator: Standard of Care<br>Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN | Diagnostic Test: Standard of Care<br>* Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN<br>* Other names: Verigene® BC-GP/GN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of anti-pseudomonal β-lactam therapy | Mean duration of anti-pseudomonal β-lactam therapy | 4 days after randomization | 
| Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy | Mean duration of MRSA therapy | 4 days after randomization |