T2Bacteria Panel Pivotal Study

Bacteremia Clinical Trial

— T2Bacteria  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02535468
• Other study ID #: PRO-00400
• Status: Completed
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2018
• Source: T2 Biosystems
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2430
• Est. completion date: June 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bacteremia

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
T2 Biosystems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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