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
2 other identifiers
observational
4,009
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2016
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
March 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2017
CompletedSeptember 27, 2017
September 1, 2017
4 months
January 11, 2016
September 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Comparison Study - AST Performance
Approximately 9 months (including pre-clinical phase)
Eligibility Criteria
Clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.
You may qualify if:
- De-identified positive blood culture specimens (6 mL aliquot)
- Seeded blood culture specimens (stock) from archived bacterial and yeast isolates
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Banner Health- Laboratory Sciences of Arizona
Gilbert, Arizona, 85234, United States
Accelerate Diagnostics Inc.
Tucson, Arizona, 85714, United States
UCLA Medical Center
Los Angeles, California, 90046, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
MRI Global
Palm Bay, Florida, 32909-2211, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1396, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Lab Alliance of Central New York LLC
Liverpool, New York, 13088, United States
The Ohio State University
Columbus, Ohio, 43205, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
med fusion LLC
Lewisville, Texas, 75067, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53276, United States
Biospecimen
Frozen positive blood cultures and bacterial and yeast isolates
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Constance Bridges, B.S., MBA
Accelerate Diagnostics, Inc.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2016
First Posted
March 25, 2016
Study Start
January 1, 2016
Primary Completion
May 1, 2016
Study Completion
January 12, 2017
Last Updated
September 27, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share