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NCT02535468 · ClinicalTrials.gov registry record

T2Bacteria Panel Pivotal Study

A clinical trial of Bacteremia, sponsored by T2 Biosystems.

Completed
Registry status
2,430
Enrollment target
3
Study locations

NCT02535468 is a study of Bacteremia that has completed, run by T2 Biosystems. The registered enrollment target is 2,430 participants, below the 7,356-participant average among 11 other Bacteremia trials with a reported enrollment target (67% lower). The trial reports 3 study locations across 3 states.

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The verdict

NCT02535468, a study of Bacteremia, has completed, sponsored by T2 Biosystems.

COMPLETED
Registry status
2,430 participants
Enrollment target
3
Study locations

Study 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 Studied

Study Locations (3)

Michigan

  • Henry Ford Health System - Detroit

Pennsylvania

  • University of Pittsburgh Medical Center - Pittsburgh

Rhode Island

  • Rhode Island Hospital - Providence

Trial Details

FieldValue
Enrollment Target 2,430 participants
Start Date 2015-12
Est. Completion 2016-06

Sponsor

T2 Biosystems

7 total trials

What the Registry Record Tells You About NCT02535468

The ClinicalTrials.gov registry entry for NCT02535468 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 2,430 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,356-participant average among 11 other Bacteremia trials with a reported enrollment target (67% lower). The listed sponsor is T2 Biosystems, which has 7 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Bacteremia appearing as the primary indexed condition, and to 0 interventions.

NCT02535468 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Michigan, Pennsylvania, Rhode Island.

Frequently Asked Questions

What is clinical trial NCT02535468 about?

NCT02535468 is a clinical study titled "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 collec...

What is the current status of trial NCT02535468?

This trial is currently completed. The enrollment target is 2,430 participants. The study started on 2015-12. Estimated completion is 2016-06.

What conditions does trial NCT02535468 study?

This clinical trial studies the following conditions: Bacteremia.

Who is sponsoring clinical trial NCT02535468?

This trial is sponsored by T2 Biosystems, which has 7 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02535468 being conducted?

This trial has 3 study locations across Michigan, Pennsylvania, Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.