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

Bacteremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02719769
• Other study ID #: CP000004
• Secondary ID: CP00002
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: September 25, 2017
• Start date: January 2016
• Est. completion date: January 12, 2017

Study information

• Verified date: September 2017
• Source: Accelerate Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4009
• Est. completion date: January 12, 2017
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bacteremia
• Fungemia

Locations

Country	Name	City	State
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	The Ohio State University	Columbus	Ohio
United States	Geisinger Clinic	Danville	Pennsylvania
United States	Banner Health- Laboratory Sciences of Arizona	Gilbert	Arizona
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	med fusion LLC	Lewisville	Texas
United States	Lab Alliance of Central New York LLC	Liverpool	New York
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	MRI Global	Palm Bay	Florida
United States	Mayo Clinic	Rochester	Minnesota
United States	Accelerate Diagnostics Inc.	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Accelerate Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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