Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Accelerate Diagnostics, Inc.774 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

774

Conditions

Bloodstream Infection

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Duration of anti-pseudomonal β-lactam therapy

Mean duration of anti-pseudomonal β-lactam therapy

Time frame: 4 days after randomization

Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy

Mean duration of MRSA therapy