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

April 10, 2020 updated by: Accelerate Diagnostics, Inc.

Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Due to Gram-Negative Rods

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care
Diagnostic test: Standard of Care
Standard blood culture work up as determined by the site's microbiology lab.
Active Comparator: Pheno
Diagnostic test: Accelerate Pheno
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desirability of Outcome Ranking (DOOR) - composite outcome
Time Frame: 30 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Accelerate Diagnostics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 30, 2019

Primary Completion (Anticipated)

June 30, 2020

Study Completion (Anticipated)

August 31, 2020

Study Registration Dates

First Submitted

November 15, 2018

First Submitted That Met QC Criteria

November 15, 2018

First Posted (Actual)

November 19, 2018

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 10, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECP000002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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