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

Primary Purpose

Gram-negative Bacteremia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Accelerate Pheno
Standard of Care
Sponsored by
Accelerate Diagnostics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gram-negative Bacteremia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Pheno

    Standard of Care

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    November 15, 2018
    Last Updated
    April 10, 2020
    Sponsor
    Accelerate Diagnostics, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03745014
    Brief Title
    Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Gram-Negative Rod Bacteremia
    Official Title
    Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Due to Gram-Negative Rods
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No sites identified with IRB approval
    Study Start Date
    September 30, 2019 (Anticipated)
    Primary Completion Date
    June 30, 2020 (Anticipated)
    Study Completion Date
    August 31, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Accelerate Diagnostics, Inc.

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gram-negative Bacteremia

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Pheno
    Arm Type
    Active Comparator
    Arm Title
    Standard of Care
    Arm Type
    Active Comparator
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Accelerate Pheno
    Intervention Description
    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.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Standard of Care
    Intervention Description
    Standard blood culture work up as determined by the site's microbiology lab.
    Primary Outcome Measure Information:
    Title
    Desirability of Outcome Ranking (DOOR) - composite outcome
    Description
    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
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

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

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