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

Gram-negative Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03745014
• Other study ID #: ECP000002
• Status: Withdrawn
• Phase: N/A
• Start date: September 30, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: April 2020
• Source: Accelerate Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bacteremia
• Gram-negative Bacteremia

Intervention

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.
• Standard of Care
Standard blood culture work up as determined by the site's microbiology lab.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Accelerate Diagnostics, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Desirability of Outcome Ranking (DOOR) - composite outcome	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	30 days