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T2Resistance - Detection of Resistance Related Genes
NCT05231187 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05231187
The ClinicalTrials.gov registry entry for NCT05231187 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,566 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is T2 Biosystems, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05231187 reports 10 study locations spanning 10 distinct geographic areas — top geographies include Alabama, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05231187?
The interventions under investigation include: T2Resistance Panel (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05231187?
This trial is sponsored by T2 Biosystems, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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