T2Bacteria Panel Pivotal Study

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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Key information

Conditions

Bacteremia Bacterial Infections Bacterial Infections and Mycoses Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Henry Ford Health System, Detroit, Michigan, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Sensitivity

Time frame: Up to 19 hours post blood collection

The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. PPA will estimated based on the positive T2Bacteria detections of contrived clinical samples.
Specificity

Time frame: Up to 19 hours post blood collection

The primary endpoint of estimated specificity will be determined by comparing the negative blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. NPA will be estimated based on the negative contrived clinical samples.

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Sponsors and collaborators

Lead sponsor

T2 Biosystems

Industry

Registry information

Acronym: T2Bacteria

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Aug 28, 2015
Registry last updated: Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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