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NCT05231187 · ClinicalTrials.gov registry record
T2Resistance - Detection of Resistance Related Genes
A clinical trial of Resistance Bacterial, sponsored by T2 Biosystems.
- Completed
- Registry status
- 1,566
- Enrollment target
- 10
- Study locations
NCT05231187: Completed study of Resistance Bacterial, sponsored by T2 Biosystems.
NCT05231187 is a study of Resistance Bacterial that has completed, run by T2 Biosystems. The registered enrollment target is 1,566 participants. The trial reports 10 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05231187, a study of Resistance Bacterial, has completed, sponsored by T2 Biosystems.
- COMPLETED
- Registry status
- 1,566 participants
- Enrollment target
- 10
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms: 1. Prospective arm: positive percent agreement (PPA) and negative percent agreement (NPA) against genetic determinants of resistance detected in whole blood clinical samples or isolates collected from positive blood cultures prospectively collected clinical samples of whole blood. 2. Contrived arm: positive percent agreement (PPA) and negative percent agreement (NPA) against samples with known status, via spiking healthy whole blood samples with bacterial strains harboring the resistance gene targets on the T2Resistance Panel. 3. Healthy donor arm: negative percent agreement (NPA) with presumed negativity of healthy donor whole blood samples. The data from all arms of the study will be used to support the Premarket Notification for the T2Resistance Panel to the U.S. Food and Drug Administration. Primary Endpoints The primary endpoints of this study with the T2Resistance Panel are estimated sensitivity, specificity, and safety.
Primary Outcome
Positive concordance between positive T2Resistance panel results for positive samples.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST T2Resistance Panel
Study Locations (10)
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Zuckerberg San Francisco General Hospital - San Francisco
Florida
- Tampa General Hospital - Tampa
Louisiana
- Ochsner Medical Center - New Orleans
Maryland
- Johns Hopkins University - Baltimore
Missouri
- University Health, Truman Medical Center - Kansas City
New York
- New York University Langone Health - Brooklyn
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,566 participants |
| Start Date | 2022-01-21 |
| Est. Completion | 2024-04-24 |
What the finished NCT05231187 record still lists
NCT05231187 is an observational study that tracks outcomes without assigning an intervention. Its 1,566 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Resistance Bacterial appearing as the primary indexed condition, and to 1 intervention - of which T2Resistance Panel is the first listed.
NCT05231187 lists 10 locations in 10 states (Alabama, California, Florida).
Frequently Asked Questions
What is clinical trial NCT05231187 about?
NCT05231187 is a clinical study titled "T2Resistance - Detection of Resistance Related Genes". The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms: 1. Prospective arm: positive percent agreement (PPA) and negative percent agreement (NPA) against genetic determinants of resistance detected in wh...
What is the current status of trial NCT05231187?
This trial is currently completed. The enrollment target is 1,566 participants. The study started on 2022-01-21. Estimated completion is 2024-04-24.
What conditions does trial NCT05231187 study?
This clinical trial studies the following conditions: Resistance Bacterial.
What interventions are being tested in trial NCT05231187?
The interventions under investigation include: T2Resistance Panel (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT05231187?
This trial is sponsored by T2 Biosystems, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05231187 being conducted?
This trial has 10 study locations across Alabama, California, Florida, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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