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

NCT ID: NCT02719769

Last Updated: 2017-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4009 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-12

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bacteremia Fungemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Accelerate Diagnostics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Constance Bridges, B.S., MBA

Role: PRINCIPAL_INVESTIGATOR

Accelerate Diagnostics, Inc.

Locations

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Banner Health- Laboratory Sciences of Arizona

Gilbert, Arizona, United States

Site Status

Accelerate Diagnostics Inc.

Tucson, Arizona, United States

Site Status

UCLA Medical Center

Los Angeles, California, United States

Site Status

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

MRI Global

Palm Bay, Florida, United States

Site Status

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Lab Alliance of Central New York LLC

Liverpool, New York, United States

Site Status

The Ohio State University

Columbus, Ohio, United States

Site Status

Geisinger Clinic

Danville, Pennsylvania, United States

Site Status

med fusion LLC

Lewisville, Texas, United States

Site Status

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CP00002

Identifier Type: OTHER

Identifier Source: secondary_id

CP000004

Identifier Type: -

Identifier Source: org_study_id