Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures

Bloodstream Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03744728
• Other study ID #: ECP000001
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 23, 2019
• Est. completion date: June 2023

Study information

• Verified date: April 2022
• Source: Accelerate Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 774
• Est. completion date: June 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection
• Sepsis

Intervention

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

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Accelerate Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of anti-pseudomonal ß-lactam therapy	Mean duration of anti-pseudomonal ß-lactam therapy	4 days after randomization
Primary	Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy	Mean duration of MRSA therapy	4 days after randomization