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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: Completed study of Bacteremia, sponsored by T2 Biosystems.
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. According to ClinicalTrials.gov, the official US trial registry.
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".
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 2,430 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-06 |
What the finished NCT02535468 record still lists
NCT02535468 is an observational study that tracks outcomes without assigning an intervention. Its 2,430 participants enrollment target places it among the larger protocols in the corpus, below the 7,356-participant average among 11 other Bacteremia trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Bacteremia appearing as the primary indexed condition, and to 0 interventions.
NCT02535468 reports a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT02535468's enrollment target sits among peer trials
2,430 5th of 11 higher than 7 of 11 other Bacteremia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bacteremia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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