Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Accelerate Diagnostics

Status: Unknown

Conditions: Bloodstream Infection

Treatments: Diagnostic Test: Standard of Care; Diagnostic Test: Accelerate PhenoTest™ BC kit

Study type: Interventional

Funder types: Industry

Identifiers

NCT03744728

ECP000001

Details and patient eligibility

About

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.

Enrollment: 774 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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774 participants in 2 patient groups

Accelerate Pheno

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Accelerate PhenoTest™ BC kit

Standard of Care

Active Comparator group

Description:

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

Treatment:

Diagnostic Test: Standard of Care