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Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Urinary Tract Infections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03745014
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Information provided by (Responsible Party):
Accelerate Diagnostics, Inc.

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 from a urinary source. 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.

Condition or disease Intervention/treatment Phase
Gram-negative Bacteremia Diagnostic Test: Accelerate Pheno Diagnostic Test: Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Urinary Tract Infections Due to Gram-Negative Rods
Estimated Study Start Date : December 15, 2018
Estimated Primary Completion Date : December 15, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Active Comparator: Standard of Care Diagnostic Test: Standard of Care
Standard blood culture work up as determined by the site's microbiology lab.

Primary Outcome Measures :
  1. 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 from a urinary source compared to the standard of care

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  • Urinary analytical (urinalysis or dipstick) criteria as agreed upon with the investigator and the microbiology labs reporting criteria.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03745014

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Contact: Amira A Bhalodi 520-260-5957

Sponsors and Collaborators
Accelerate Diagnostics, Inc.

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Responsible Party: Accelerate Diagnostics, Inc. Identifier: NCT03745014     History of Changes
Other Study ID Numbers: ECP000002
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Urinary Tract Infections
Bacterial Infections
Disease Susceptibility
Urologic Diseases
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Anti-Bacterial Agents