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T2Resistance - Detection of Resistance Related Genes

NCT05231187 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1566

Last updated 2024-12-19

No results posted yet for this 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

  • Resistance Bacterial

Interventions

DIAGNOSTIC_TEST

T2Resistance Panel

The T2Resistance Panel is an in vitro diagnostic medical device that runs on the T2Dx instrument and detects bacterial markers that are commonly associated with antibiotic resistance. T2Resistance Panel detects thirteen (13) markers of resistance in seven detection channels: 1. blaKPC 2. blaCTX-M 3. blaNDM / blaVIM / blaIMP 4. blaOXA-48 Group 5. vanA / vanB 6. mecA / mecC 7. AmpC (blaCMY / blaDHA)

Sponsors & Collaborators

Principal Investigators

  • Roger Smith, Ph.D. · T2 Biosystems

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-21
Primary Completion
2023-05-31
Completion
2024-04-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05231187 on ClinicalTrials.gov