T2Bacteria Panel Pivotal Study

T2 Biosystems2,430 enrolled

Overview

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".

Study Type

OBSERVATIONAL

Enrollment

2,430

Conditions

Bacteremia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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.

Locations (3)

Henry Ford Health System

Detroit, Michigan, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Outcomes

Primary Outcomes

Sensitivity

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.

Time frame: Up to 19 hours post blood collection

Specificity

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.

Time frame: Up to 19 hours post blood collection

Data from ClinicalTrials.gov

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