Resistance BacterialNCT05231187
T2Resistance - Detection of Resistance Related Genes
An observational study of Resistance Bacterial, run by T2 Biosystems at 10 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resistance Bacterial
- What is being tested?
- T2Resistance Panel
- How many people
- 1,566 participants
- Where
- 10 sitesUnited States
- Study dates
- 21 Jan 2022to 24 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting at the Investigational Site (Hospital, Clinical) and having a diagnostic blood culture ordered per routine standard of care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 352494
New York University Langone Health
Brooklyn, New York, 11220
University of Texas Health Science Center
Houston, Texas, 77030
University Health, Truman Medical Center
Kansas City, Missouri, 64108
Ochsner Medical Center
New Orleans, Louisiana, 70121
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: T2Resistance 510(k) Study Protocol - Detection and Identification of Several Classes of Resistance Genes in Both Gram-positive and Gram-negative Pathogens
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms:
- 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.
- 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.
- Healthy donor arm: negative percent agreement (NPA) with presumed negativity of healthy donor whole blood samples.
Read more
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.
Read the 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:
- 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.
- 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.
- 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:
- 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
- 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:
- 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
- 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
- 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.
- Conditions
- Resistance Bacterial
- Being tested
- T2Resistance Panel
- Keywords
- Antibiotic resistant markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T2Resistance PanelDiagnostic test
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:
- blaKPC
- blaCTX-M
- blaNDM / blaVIM / blaIMP
- blaOXA-48 Group
- vanA / vanB
- mecA / mecC
- AmpC (blaCMY / blaDHA)
| Study group | Role | What they receive |
|---|---|---|
| Prospective Arm | Subjects has had a diagnostic blood culture ordered per routine standard of care. Receives: Diagnostic Test: T2Resistance Panel | |
| Contrived Arm | Samples of healthy whole blood spiked with bacterial strains harboring the resistance gene targets on the T2Resistance Panel. Receives: Diagnostic Test: T2Resistance Panel | |
| Healthy Donor Arm | Healthy donor subjects. Receives: Diagnostic Test: T2Resistance Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity - Prospective
Positive concordance between positive T2Resistance panel results for positive samples.
Measured: Six months from collection, maximum.
Specificity - Prospective
Negative concordance between a negative ("Target not Detected") result on the T2Resistance Panel and a negative sequencing result or a known negative sample.
Measured: Six months from collection, maximum.
Safety / Adverse Events
Potential adverse events associated with the collection of blood samples for T2Resistance Panel Testing.
Measured: During patient blood draw or immediately after blood draw, typically <1 hour.
Secondary outcomes (2)
Sensitivity - Contrived
Concordance between T2Resistance Panel results and positive blood culture, and contrived samples.
Measured: Six months from collection, maximum.
Specificity - Contrived
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.
Measured: Six months from collection, maximum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start21 Jan 2022
- Primary completion31 May 2023
- Study completion24 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resistance BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,566 participants (actual)
Sponsor and investigators
- Lead sponsor
- T2 Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Roger Smith, Ph.D., Study director, T2 Biosystems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231187
- Sponsor's protocol ID
- 210-11147
- Status last verified
- Dec 2024
- First submitted
- 28 Jan 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T2Resistance 510(k) Study Protocol - Detection and Identification of Several Classes of Resistance Genes in Both Gram-positive and Gram-negative Pathogens
- ClinicalTrials.gov ID
- NCT05231187
- Acronym / sponsor ID
- 210-11147
- Conditions
- Resistance Bacterial
- Keywords
- Antibiotic resistant markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,566 participants (actual)
- Lead sponsor
- T2 BiosystemsIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 21 Jan 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 24 Apr 2024 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the T2Resistance Panel by validating clinical performance in three study arms:
- 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.
- 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.
- 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:
- 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.
- 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.
- 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:
- 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
- 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:
- 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
- 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
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Arm | – | Diagnostic Test: T2Resistance PanelSubjects has had a diagnostic blood culture ordered per routine standard of care. |
| Contrived Arm | – | Diagnostic Test: T2Resistance PanelSamples of healthy whole blood spiked with bacterial strains harboring the resistance gene targets on the T2Resistance Panel. |
| Healthy Donor Arm | – | Diagnostic Test: T2Resistance PanelHealthy donor subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at the Investigational Site (Hospital, Clinical) and having a diagnostic blood culture ordered per routine standard of care.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T2Resistance PanelThe 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) | Diagnostic test | Contrived Arm, Healthy Donor Arm, Prospective Arm |
Primary outcome
Sensitivity - Prospective
Time frame: Six months from collection, maximum.
Positive concordance between positive T2Resistance panel results for positive samples.
Specificity - Prospective
Time frame: 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.
Safety / Adverse Events
Time frame: 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.
2 secondary outcomes
Sensitivity - Contrived
Time frame: Six months from collection, maximum.
Specificity - Contrived
Time frame: Six months from collection, maximum.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger Smith, Ph.D. study director
T2 Biosystems
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Resistance Bacterial, run by T2 Biosystems at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity - Prospective (time frame: Six months from collection, maximum.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.