Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05231187
Study type Observational
Source T2 Biosystems
Contact
Status Active, not recruiting
Phase
Start date January 10, 2022
Completion date November 2023

See also
  Status Clinical Trial Phase
Recruiting NCT06313619 - Decreasing Irrational Antimicrobial Use in Bangladesh: A Digital Intervention Program N/A
Completed NCT03676751 - MORDOR II Burkina Faso: Longitudinal Trial Phase 4
Recruiting NCT04224987 - Azithromycin for Child Survival in Niger: Mortality and Resistance Trial Phase 4
Active, not recruiting NCT04567368 - TB-CAPT MTB/XDR Study
Not yet recruiting NCT04652284 - Effectiveness of Rifabutin for Treatment of Helicobacter Pylori Phase 3
Completed NCT03382470 - Impact of Antimicrobial Stewardship Programs in the Global Setting
Completed NCT03477084 - Understanding and Modeling Reservoirs, Vehicles and Transmission of ESBL-producing Enterobacteriaceae in the Community and Long Term Care Facilities
Recruiting NCT06322173 - Molecular Diagnostics of Bacterial Infections and Antibiotic Resistance in Blood Samples and Rectal Swabs Using Advanced NGS Sequencing Methods N/A
Recruiting NCT03863249 - Use of the xCELLigence System for Quantification of Bacterial Biofilm's Real Time Formation and Antibiotics Selection. Phase 4
Recruiting NCT04188743 - Decolonization of Gram-negative Multi-resistant Organisms (MDRO) With Donor Microbiota (FMT) Phase 2/Phase 3
Recruiting NCT05288023 - Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR) Phase 4
Completed NCT03937245 - Epidemiology and Determinants of Outcomes of Hospital Acquired Blood Stream Infections in the Intensive Care
Not yet recruiting NCT06352554 - Susceptibility Testing In Neisseria Gonorrhoeae (STING) Study, Assessing the Performance of a New Rapid Test for Gonorrhoea Antibiotic Resistance, in a Cohort of 100 Culture Positive Neisseria Gonorrhoeae Infections