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

Not Applicable

Withdrawn

• Conditions: Gram-negative Bacteremia
• Interventions: Diagnostic Test: Accelerate Pheno; Diagnostic Test: Standard of Care

• Registration Number: NCT03745014
• Lead Sponsor: 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-15
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Study Start: 2019-09-30
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-10
• Last Update Posted: 2020-04-14
• Primary Completion: 2020-06-30
• Study Completion: 2020-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pheno	Accelerate Pheno	-
Standard of Care	Standard of Care	-

Primary Outcome Measures

Name	Time	Method
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