NCT03744728

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 774 (actual)
• Sponsor: Accelerate Diagnostics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DIAGNOSTIC_TEST	Standard of Care	Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN

Timeline

• Start date: 2019-05-23
• Primary completion: 2023-04-01
• Completion: 2023-06-01
• First posted: 2018-11-16
• Last updated: 2022-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study