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Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

NCT03744728 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 774

Last updated 2022-04-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Accelerate Diagnostics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-23
Primary Completion
2023-04-30
Completion
2023-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03744728 on ClinicalTrials.gov