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Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates

NCT04295915 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 731

Last updated 2022-04-22

No results posted yet for this study

Summary

This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.

Conditions

  • Bacteremia

Interventions

DEVICE

Specimens that meet inclusion criteria

Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.

Sponsors & Collaborators

  • Accelerate Diagnostics, Inc.

    lead INDUSTRY

Principal Investigators

  • Shelley Campeau · Accelerate Diagnostics, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2021-12-02
Completion
2022-04-19
FDA Device
Yes

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 NCT04295915 on ClinicalTrials.gov