T2Resistance - Detection of Resistance Related Genes
- Conditions
- Resistance Bacterial
- Interventions
- Diagnostic Test: T2Resistance Panel
- Registration Number
- NCT05231187
- Lead Sponsor
- T2 Biosystems
- Brief 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.
- Detailed Description
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.
Sensitivity
The estimated sensitivity of the T2Resistance Panel will be derived from two metrics:
1. Prospective arm: positive concordance between a positive result on the T2Resistance Panel and a positive sequencing result from a whole blood sample or isolate from positive blood culture
2. Contrived arm: positive concordance between a positive result on the T2Resistance Panel and a sample spiked with a bacterial isolates sequence confirmed to be harboring a known resistance gene on the T2Resistance Panel.
The Contrived arm of the study will consist of ≥ 350 whole blood samples spiked with titer levels ranging from \< 1 CFU/mL to 100 CFU/mL. These samples will be provided to selected test sites for testing. Sensitivity values will be calculated separately for each channel and study arm, e.g., Prospective and Contrived study arms for blaKPC, blaCTX-M, blaNDM / blaVIM / blaIMP, blaOXA-48 Group, vanA / vanB, mecA / mecC and AmpC (blaCMY / blaDHA) channels.
Specificity
The estimated specificity of the T2Resistance Panel will be derived from three metrics:
1. Prospective arm: negative concordance between a negative ("Target not Detected") result on the T2Resistance Panel and a negative sequencing result from whole blood sample or isolate from positive blood culture
2. Healthy donor arm: negative concordance between a negative ("Target not Detected") result on the T2Resistance Panel and a presumed negativity of healthy donor whole blood sample
3. Contrived arm: negative concordance between a negative ("Target not Detected") result in a given channel of the T2Resistance Panel and the presence of a spiked bacteria known to not harbor the given resistance gene on the T2Resistance Panel
Specificity values will be calculated separately for each channel and study arm, e.g., Prospective, Healthy donor, and Contrived study arms for blaKPC, blaCTX-M, blaNDM / blaVIM / blaIMP, blaOXA-48 Group, vanA / vanB, mecA / mecC and AmpC (blaCMY / blaDHA) channels.
Safety
There are no expected adverse events that are directly related to the T2Resistance Panel and the T2Dx Instrument as a result of participating in this study. Since the device does not come in contact with the patients and the test results are not used in clinical practice as part of standard of care, the only adverse events associated with study participation is the collection of blood samples for T2Resistance Panel testing.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1566
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective Arm T2Resistance Panel Subjects has had a diagnostic blood culture ordered per routine standard of care. Healthy Donor Arm T2Resistance Panel Healthy donor subjects. Contrived Arm T2Resistance Panel Samples of healthy whole blood spiked with bacterial strains harboring the resistance gene targets on the T2Resistance Panel.
- Primary Outcome Measures
Name Time Method Safety / Adverse Events During patient blood draw or immediately after blood draw, typically <1 hour. Potential adverse events associated with the collection of blood samples for T2Resistance Panel Testing.
Sensitivity - Prospective Six months from collection, maximum. Positive concordance between positive T2Resistance panel results for positive samples.
Specificity - Prospective Six months from collection, maximum. Negative concordance between a negative ("Target not Detected") result on the T2Resistance Panel and a negative sequencing result or a known negative sample.
- Secondary Outcome Measures
Name Time Method Specificity - Contrived Six months from collection, maximum. Concordance between a negative ("Target not Detected") result on the T2Resistance Panel and sensitivity results associated with antibiotic susceptibility testing from positive blood culture samples or positive contrived samples.
Sensitivity - Contrived Six months from collection, maximum. Concordance between T2Resistance Panel results and positive blood culture, and contrived samples.
Trial Locations
- Locations (10)
University of Texas Health Science Center
🇺🇸Houston, Texas, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
New York University Langone Health
🇺🇸Brooklyn, New York, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
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
University Health, Truman Medical Center
🇺🇸Kansas City, Missouri, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States