Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates

Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System With New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens

This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Study Overview

• Status: Completed
• Conditions: Bacteremia
• Intervention / Treatment: Device: Specimens that meet inclusion criteria

Detailed Description

This clinical study entitled "Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens" is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017.

Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens.

The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB).

It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

• Study Type: Observational
• Enrollment (Actual): 731

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85714
      • Accelerate Diagnostics
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State-Hershey Medical Center
  • Texas
    • Lewisville, Texas, United States, 75067
      • Quest/med fusion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical or contrived (seeded bacterial isolate) specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.

Description

Inclusion Criteria:

• Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system
• Positive blood culture sample containing gram-negative rods according to Gram stain results
• For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded
• A minimum sample volume of 2.0 mL
• Seeded blood culture specimens derived from archived bacterial

Exclusion Criteria:

• Blood culture positivity is > 8 hours prior to initiation of testing with the Accelerate Pheno™ system
• Insufficient (less than 2.0 mL) remnant sample volume
• From a patient that has already been enrolled in the study
• Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media
• Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Specimens that meet inclusion criteria	Device: Specimens that meet inclusion criteria; Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method	Approximately 4 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results	Approximately 2 months

Collaborators and Investigators

• Sponsor: Accelerate Diagnostics, Inc.
• Investigators: Study Director: Shelley Campeau, Accelerate Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2020
• Primary Completion (ACTUAL): December 2, 2021
• Study Completion (ACTUAL): April 19, 2022

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (ACTUAL): March 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Positive blood culture
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: CP000026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No