BacteremiaT2BacteriaNCT02535468
T2Bacteria Panel Pivotal Study
An observational study of Bacteremia, run by T2 Biosystems at 3 sites in United States.
Trial summary
The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Bacteremia
- How many people
- 2,430 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2015to Jun 2016
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Candidates participating in the prospective arm of the study will come from the hospital population who have had a blood culture ordered per routine standard of care. The contrived arm of the study is open to any participants that meet the study enrollment criteria. The study population for both arms is defined as all subjects who meet the study eligibility criteria, provide informed consent, and provide the clinical specimens under this protocol.
Who may be able to join
- Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
- Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
- Subject is between 18-95 years of age.
Who cannot join
- Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
- Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
- Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Henry Ford Health System
Detroit, Michigan, 48202
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".
- Conditions
- Bacteremia
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective Arm | Not described | |
| Contrived Arm | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. PPA will estimated based on the positive T2Bacteria detections of contrived clinical samples.
Measured: Up to 19 hours post blood collection
Specificity
The primary endpoint of estimated specificity will be determined by comparing the negative blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. NPA will be estimated based on the negative contrived clinical samples.
Measured: Up to 19 hours post blood collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startDec 2015
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BacteremiaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,430 participants (actual)
Sponsor and investigators
- Lead sponsor
- T2 Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535468
- Sponsor's protocol ID
- PRO-00400
- Acronym
- T2Bacteria
- Status last verified
- Aug 2018
- First submitted
- 25 Aug 2015
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T2Bacteria Panel Pivotal Study
- ClinicalTrials.gov ID
- NCT02535468
- Acronym / sponsor ID
- T2Bacteria / PRO-00400
- Conditions
- Bacteremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,430 participants (actual)
- Lead sponsor
- T2 BiosystemsIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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 demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective Arm | – | – |
| Contrived Arm | – | – |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Candidates participating in the prospective arm of the study will come from the hospital population who have had a blood culture ordered per routine standard of care. The contrived arm of the study is open to any participants that meet the study enrollment criteria. The study population for both arms is defined as all subjects who meet the study eligibility criteria, provide informed consent, and provide the clinical specimens under this protocol.
Key inclusion criteria (3 listed)
- Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
- Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
- Subject is between 18-95 years of age.
Key exclusion criteria (3 listed)
- Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
- Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
- Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity
Time frame: Up to 19 hours post blood collection
The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. PPA will estimated based on the positive T2Bacteria detections of contrived clinical samples.
Specificity
Time frame: Up to 19 hours post blood collection
The primary endpoint of estimated specificity will be determined by comparing the negative blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. NPA will be estimated based on the negative contrived clinical samples.
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 17 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by T2 Biosystems at 3 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 3 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 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 (time frame: Up to 19 hours post blood collection). The study lists 2 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 17 Aug 2018.