Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Bloodstream Infection
• Intervention / Treatment: Diagnostic test: Accelerate PhenoTest™ BC kit; Diagnostic test: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 774
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Accelerate Pheno; 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; 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
Active Comparator: Standard of Care; Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN	Diagnostic test: Standard of Care; Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN; Other Names: Verigene® BC-GP/GN

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Accelerate Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2019
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis
• Other Study ID Numbers: ECP000001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes