Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Not Applicable

• Conditions: Bloodstream Infection
• Interventions: Diagnostic Test: Standard of Care; Diagnostic Test: Accelerate PhenoTest™ BC kit

• Registration Number: NCT03744728
• Lead Sponsor: Accelerate Diagnostics, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-16
• Study Start: 2019-05-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-20
• Last Update Posted: 2022-04-22
• Primary Completion: 2023-04
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 774

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN
Accelerate Pheno	Accelerate PhenoTest™ BC kit	Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System

Primary Outcome Measures

Name	Time	Method
Duration of anti-pseudomonal β-lactam therapy	4 days after randomization	Mean duration of anti-pseudomonal β-lactam therapy
Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy	4 days after randomization	Mean duration of MRSA therapy

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States