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Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Primary Purpose

Bloodstream Infection

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerate PhenoTest™ BC kit
Standard of Care
Sponsored by
Accelerate Diagnostics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bloodstream Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hennepin County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Accelerate Pheno

Standard of Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Duration of anti-pseudomonal β-lactam therapy
Mean duration of anti-pseudomonal β-lactam therapy
Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy
Mean duration of MRSA therapy

Secondary Outcome Measures

Full Information

First Posted
November 15, 2018
Last Updated
April 20, 2022
Sponsor
Accelerate Diagnostics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03744728
Brief Title
Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Accelerate Diagnostics, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bloodstream Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
774 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accelerate Pheno
Arm Type
Active Comparator
Arm Description
Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN
Intervention Type
Diagnostic Test
Intervention Name(s)
Accelerate PhenoTest™ BC kit
Intervention Description
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
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
Verigene® BC-GP/GN
Intervention Description
Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN
Primary Outcome Measure Information:
Title
Duration of anti-pseudomonal β-lactam therapy
Description
Mean duration of anti-pseudomonal β-lactam therapy
Time Frame
4 days after randomization
Title
Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy
Description
Mean duration of MRSA therapy
Time Frame
4 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States

12. IPD Sharing Statement

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Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

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