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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

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.

Detailed Summary: 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.
Sponsor: Accelerate Diagnostics, Inc.

Current Primary Outcome: Comparison Study - ID Performance [ Time Frame: Approximately 9 months (including pre-clinical phase) ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome: Comparison Study - AST Performance [ Time Frame: Approximately 9 months (including pre-clinical phase) ]

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


Original Secondary Outcome: Same as current

Information By: Accelerate Diagnostics, Inc.

Dates:
Date Received: January 11, 2016
Date Started: January 2016
Date Completion: October 2016
Last Updated: June 30, 2016
Last Verified: March 2016