Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Gram-Negative Rod Bacteremia

NCT03745014 | Withdrawn FDA Device

• 1 other identifier: ECP000002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.

Conditions

Gram-negative Bacteremia

Outcome Measures

Primary Outcomes (1)

• Desirability of Outcome Ranking (DOOR) - composite outcome

  The primary endpoint is the probability that a patient will have a better DOOR when the Accelerate PhenoTest™ BC kit is used on positive blood cultures due to gram-negative rods compared to the standard of care

  30 days

Study Arms (2)

Pheno

ACTIVE COMPARATOR

Diagnostic Test: Accelerate Pheno

Standard of Care

ACTIVE COMPARATOR

Diagnostic Test: Standard of Care

Interventions

Accelerate Pheno DIAGNOSTIC_TEST

The Accelerate Pheno™ system and PhenoTest™ BC Kit 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.

Pheno

Standard of Care DIAGNOSTIC_TEST

Standard blood culture work up as determined by the site's microbiology lab.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on Gram stain)
• Blood culture drawn in the Emergency Department (ED)

You may not qualify if:

• Patients not admitted to hospital
• Patients discharged from hospital prior to blood culture positivity
• Only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
• Positive blood culture with GNR in the prior 7 days (if known at the time of randomization)
• Transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization)
• GNR plus gram-positive organism, gram-negative cocci, and/or yeast detected on blood culture Gram stain
• Deceased or palliative care at the time of randomization
• Patient who is moribund (does not survive the initial 72 hours after enrollment)

Sponsors & Collaborators

• Accelerate Diagnostics, Inc.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: September 30, 2019
• Primary Completion: June 30, 2020
• Study Completion: August 31, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04