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

Accelerate Diagnostics

Status

Withdrawn

Conditions

Gram-negative Bacteremia

Treatments

Diagnostic Test: Accelerate Pheno

Diagnostic Test: Standard of Care

Study type

Interventional

Funder types

Industry

Identifiers

NCT03745014

ECP000002

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No 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)