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

Completed

Conditions studied: Bacteremia, Fungemia

In brief

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.

Key facts

Study ID

NCT02719769

Run by

Accelerate Diagnostics, Inc.

People needed

4009

Starts

2016-01-01

Expected to finish

2017-01-12

Last updated by the study team

2017-09-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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