Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture

Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing

The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical setting. The data from this study will be used to support the 510(k) submission for FDA clearance and global registrations of the device intended for in vitro diagnostic use.

Study Overview

• Status: Completed
• Conditions: Fungemia; Bacteremia

Detailed Description

The clinical study entitled "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing" is designed to demonstrate the clinical performance of the Accelerate ID/AST System for positive blood culture identification (ID) and antimicrobial susceptibility testing (AST) in a clinical setting compared to reference results. Approximately 3,000 positive blood culture samples (across all Clinical Sites) will be tested on the investigational device and reference methods. Up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. Quality Control testing will be performed each day of testing. The study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. Positive blood culture samples must be tested on the Accelerate ID/AST System within 8 hours of positivity by the blood culture monitoring system. Testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.

• Study Type: Observational
• Enrollment (Actual): 4009

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Banner Health- Laboratory Sciences of Arizona
    • Tucson, Arizona, United States, 85714
      • Accelerate Diagnostics Inc.
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
    • Los Angeles, California, United States, 90046
      • UCLA Medical Center
  • Florida
    • Palm Bay, Florida, United States, 32909-2211
      • MRI Global
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242-1396
      • University of Iowa Hospitals and Clinics
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University School of Medicine
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • Liverpool, New York, United States, 13088
      • Lab Alliance of Central New York LLC
  • Ohio
    • Columbus, Ohio, United States, 43205
      • The Ohio State University
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Clinic
  • Texas
    • Lewisville, Texas, United States, 75067
      • med fusion LLC
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53276
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.

Description

Inclusion Criteria:

• De-identified positive blood culture specimens (6 mL aliquot)
• Seeded blood culture specimens (stock) from archived bacterial and yeast isolates

Exclusion Criteria:

• Sample volume available < 6 mL
• Positive Blood Culture sample > 8 hours post-positivity
• Sample from patient previously enrolled
• Sample from blood culture media that contain charcoal e.g., BACTAlert FA, FN bottles
• Samples from Mycobacterial-type blood culture media e.g., BACTEC Myco/F Lytic, BacT/ALERT MP Bottle, VersaTREK Myco

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison Study - ID Performance	Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target	Approximately 9 months (including pre-clinical phase)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison Study - AST Performance	Essential and Categorical Agreement with CLSI Frozen Reference Method (BMD) by Antimicrobial	Approximately 9 months (including pre-clinical phase)

Collaborators and Investigators

• Sponsor: Accelerate Diagnostics, Inc.
• Investigators: Principal Investigator: Constance Bridges, B.S., MBA, Accelerate Diagnostics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): January 12, 2017

Study Registration Dates

• First Submitted: January 11, 2016
• First Submitted That Met QC Criteria: March 24, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): September 27, 2017
• Last Update Submitted That Met QC Criteria: September 25, 2017
• Last Verified: September 1, 2017

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; Mycoses; Invasive Fungal Infections; Bacteremia; Fungemia
• Other Study ID Numbers: CP000004; CP00002 (Other Identifier: Accelerate Diagnostics)

Plan for Individual participant data (IPD)

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