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

NCT03745014 — Not applicable, Withdrawn, Accelerate Diagnostics, Inc.

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

Registry	NCT03745014
Status	Withdrawn - No sites identified with IRB approval
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, diagnostic
Sponsor	Accelerate Diagnostics, Inc. (Industry)
Conditions	Gram-negative Bacteremia
Interventions	Accelerate Pheno, Standard of Care (Diagnostic test)
Dates	start 2019-09-30 (estimated), primary completion 2020-06-30 (estimated), completion 2020-08-31 (estimated), first posted 2018-11-19, last updated 2020-04-14

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Pheno	Active comparator	Diagnostic Test: Accelerate Pheno
Standard of Care	Active comparator	Diagnostic Test: Standard of Care

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.
Standard of Care (Diagnostic test): Standard blood culture work up as determined by the site's microbiology lab.

+Outcome measures

Primary outcomes

Desirability of Outcome Ranking (DOOR) - composite outcome [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

+Eligibility

Sex: All, ages: 18 Years to any

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)