T2Resistance - Detection of Resistance Related Genes

Completed

Conditions studied: Resistance Bacterial

In brief

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.

Key facts

Study ID

NCT05231187

Run by

T2 Biosystems

People needed

1566

Starts

2022-01-21

Expected to finish

2024-04-24

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prospective Arm:
• Obtain informed consent according to institutional requirements, as needed.
• Patient has had a diagnostic blood culture ordered per routine standard of care.
• Patient is 18 years of age or older.

You may not qualify if…

• Prospective Arm
• Patient has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the patient's ability to participate in the study or impact the scientific integrity of the study.
• Patient has had previous specimens tested for the T2Resistance Panel with valid results.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Zuckerberg San Francisco General Hospital — San Francisco, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• Ochsner Medical Center — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University Health, Truman Medical Center — Kansas City, Missouri, United States
• New York University Langone Health — Brooklyn, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University of Texas Health Science Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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