Gram-negative Bacteremia
Conditions
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.
Interventions
DIAGNOSTIC_TESTAccelerate 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.
DIAGNOSTIC_TESTStandard of Care
Standard blood culture work up as determined by the site's microbiology lab.
Sponsors
Accelerate Diagnostics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed