T2Resistance - Detection of Resistance Related Genes
Public ClinicalTrials.gov record NCT05231187. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
T2Resistance 510(k) Study Protocol - Detection and Identification of Several Classes of Resistance Genes in Both Gram-positive and Gram-negative Pathogens
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05231187
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,566 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 21, 2022 (Actual)
- Primary completion
- May 31, 2023 (Actual)
- Completion
- Apr 24, 2024 (Actual)
- Last update posted
- Dec 19, 2024
2022 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 10
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 352494 | — |
| Zuckerberg San Francisco General Hospital | San Francisco | California | 94110 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| University Health, Truman Medical Center | Kansas City | Missouri | 64108 | — |
| New York University Langone Health | Brooklyn | New York | 11220 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| University of Texas Health Science Center | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05231187, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 19, 2024 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05231187 live on ClinicalTrials.gov.