T2Bacteria Panel Pivotal Study

NCT02535468 | Completed

• 1 other identifier: PRO-00400
• Study Type: observational
• Target: 2,430
• Locations: 1 country
• Sites: 3

Brief Summary

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".

Conditions

Bacteremia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Prospective Arm

Contrived Arm

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• T2 Biosystems: lead

Study Sites (3)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Bacteremia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 28, 2015
• Study Start: December 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 17, 2018

Record last verified: 2018-08

Locations

US (3)