T2Bacteria Panel Pivotal Study (T2Bacteria)

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 Overview

• Status: Completed
• Conditions: Bacteremia

• Study Type: Observational
• Enrollment (Actual): 2430

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Candidates participating in the prospective arm of the study will come from the hospital population who have had a blood culture ordered per routine standard of care. The contrived arm of the study is open to any participants that meet the study enrollment criteria. The study population for both arms is defined as all subjects who meet the study eligibility criteria, provide informed consent, and provide the clinical specimens under this protocol.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Prospective Arm
Contrived Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 19 hours post blood collection

Collaborators and Investigators

• Sponsor: T2 Biosystems

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 25, 2015
• First Submitted That Met QC Criteria: August 27, 2015
• First Posted (Estimate): August 28, 2015

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Bacteremia
• Other Study ID Numbers: PRO-00400