Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT05231187 |
Other study ID # |
210-11147 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 10, 2022 |
Est. completion date |
November 2023 |
Study information
Verified date |
September 2023 |
Source |
T2 Biosystems |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
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.