T2Bacteria Panel Pivotal Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

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The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".

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Detailed Description

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Conditions

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Bacteremia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective Arm

No interventions assigned to this group

Contrived Arm

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
* Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
* Subject is between 18-95 years of age.

Exclusion Criteria

* Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
* Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
* Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.

Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No