Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

NCT03744728 | Unknown FDA Device

• 1 other identifier: ECP000001
• Study Type: interventional
• Target: 774
• Locations: 1 country
• Sites: 1

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.

Conditions

Bloodstream Infection

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Accelerate Pheno

ACTIVE COMPARATOR

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

Standard of Care

ACTIVE COMPARATOR

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

Diagnostic Test: Standard of Care

Interventions

Accelerate PhenoTest™ BC kit DIAGNOSTIC_TEST

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

Accelerate Pheno

Standard of Care DIAGNOSTIC_TEST

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

Also known as: Verigene® BC-GP/GN

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours
• All adult (≥18 years of age)

You may not qualify if:

• 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

Sponsors & Collaborators

• Accelerate Diagnostics, Inc.: lead

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 16, 2018
• Study Start: May 23, 2019
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

US (1)