NCT02719769

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,009 (actual)
• Sponsor: Accelerate Diagnostics, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

• Bacteremia
• Fungemia

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-05-01
• Completion: 2017-01-12
• First posted: 2016-03-25
• Last updated: 2017-09-27

Locations

14 sites across 1 country: United States