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

NCT02719769 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4009

Last updated 2017-09-27

No results posted yet for this study

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.

Conditions

  • Bacteremia
  • Fungemia

Sponsors & Collaborators

  • Accelerate Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Constance Bridges, B.S., MBA · Accelerate Diagnostics, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-05-31
Completion
2017-01-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719769 on ClinicalTrials.gov