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

Sponsor
Accelerate Diagnostics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02719769
Collaborator
(none)
4,009
Enrollment
14
Locations
12.4
Actual Duration (Months)
286.4
Patients Per Site
23.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    4009 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing
    Actual Study Start Date :
    Jan 1, 2016
    Actual Primary Completion Date :
    May 1, 2016
    Actual Study Completion Date :
    Jan 12, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Comparison Study - ID Performance [Approximately 9 months (including pre-clinical phase)]

      Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target

    Secondary Outcome Measures

    1. Comparison Study - AST Performance [Approximately 9 months (including pre-clinical phase)]

      Essential and Categorical Agreement with CLSI Frozen Reference Method (BMD) by Antimicrobial

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Accelerate Diagnostics, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Accelerate Diagnostics, Inc.
    ClinicalTrials.gov Identifier:
    NCT02719769
    Other Study ID Numbers:
    • CP000004
    • CP00002
    First Posted:
    Mar 25, 2016
    Last Update Posted:
    Sep 27, 2017
    Last Verified:
    Sep 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Accelerate Diagnostics, Inc.
    Positive Blood Culture
    Additional relevant MeSH terms:
    Bacteremia
    Fungemia

    Study Results

    No Results Posted as of Sep 27, 2017