CandidemiadirecT2NCT01752166
Detecting Infections Rapidly and Easily for Candidemia Trial - Part 2 (direcT2 Study)
An observational study of Candidemia, run by T2 Biosystems at 8 sites in United States.
Trial summary
The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results and/or known Candida positive status of prospectively collected and contrived (i.e. Candida-spiked) clinical specimens. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Candidemia
- How many people
- 1,500 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2013to Apr 2014
- 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: Adult patients who have had a blood culture ordered, per routine standard of care
Who may be able to join
- Subject or subject's authorized representative 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 blood culture ordered, per routine standard of care.
- 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 T2Candida assay with valid results.
- Subject has had an anti-fungal drug administered through the same port or central line as is used to collect the clinical research specimens.
- Treatment of subject with any novel drug compound within 30 days prior to the collection of T2 blood specimens.
- T2 clinical specimen, Tube A contains <3ml of blood.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Georgia Regents University
Augusta, Georgia, 30912
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006
Henry Ford Health System
Detroit, Michigan, 48202
MD Anderson Cancer Center
Houston, Texas, 77030
University of Houston College of Pharmacy
Houston, Texas, 77030
University of Texas Health Science Center
Houston, Texas, 77030
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Prospective Collection and Testing of Un-Spiked and Candida-Spiked Fresh Whole Blood Specimens From Patients Who Have Been Referred For a Diagnostic Blood Culture
The purpose of this study is to validate clinical performance (i.e. estimated sensitivity and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results and/or known Candida positive status of prospectively collected and contrived (i.e. Candida-spiked) clinical specimens.
Read the detailed description
This study will prospectively collect and analyze whole blood T2 clinical research specimens and concomitant blood culture specimens from patients who have been referred for a blood culture per routine standard of care. Additional analysis of blinded, contrived (i.e. Candida spiked and un-spiked whole blood) specimens will be completed by study sites to augment the analysis of Candida positive blood specimens prospectively obtained from the study population.
The clinical performance of the T2 Candida test on the T2 Dx Instrument will be evaluated by calculating the:
- Estimated clinical specificity of the T2Candida test results compared to Candida negative blood culture results in prospectively collected specimens, and the
- Estimated sensitivity of the T2 Candida test results compared to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to Candida positive blood culture results in prospectively collected clinical specimens.
- Conditions
- Candidemia
- Keywords
- Candida, Candidemia, Blood culture, Diagnostics
- Medical subject headings
- Candidemia, Torulopsis
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 |
|---|---|---|
| Blood culture | Subjects have had a blood culture ordered, per routine standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity
Estimated specificity of the T2Candida test will be examined by comparing T2Candida test results from prospectively collected T2 clinical specimens to blood culture results from specimens that are culture negative for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens.
Measured: Up to 19 hours post blood collection
Sensitivity
Estimated sensitivity of the T2Candida test will be examined by comparing T2Candida test results to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to blood culture results from specimens that are culture positive for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens.
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 posted19 Dec 2012 (estimated)
- Study startJul 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CandidemiaStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- T2 Biosystems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Pappas, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752166
- Sponsor's protocol ID
- PRO-00031
- Acronym
- direcT2
- Status last verified
- May 2014
- First submitted
- 14 Dec 2012
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Mylonakis E, Clancy CJ, Ostrosky-Zeichner L, Garey KW, Alangaden GJ, Vazquez JA, Groeger JS, Judson MA, Vinagre YM, Heard SO, Zervou FN, Zacharioudakis IM, Kontoyiannis DP, Pappas PG. T2 magnetic resonance assay for the rapid diagnosis of candidemia in whole blood: a clinical trial. Clin Infect Dis. 2015 Mar 15;60(6):892-9. doi: 10.1093/cid/ciu959. Epub 2015 Jan 12.
PubMed 25586686
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection and Testing of Un-Spiked and Candida-Spiked Fresh Whole Blood Specimens From Patients Who Have Been Referred For a Diagnostic Blood Culture
- ClinicalTrials.gov ID
- NCT01752166
- Acronym / sponsor ID
- direcT2 / PRO-00031
- Conditions
- Candidemia
- Keywords
- Candida, Candidemia, Blood culture, Diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- T2 BiosystemsIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 19 Dec 2012 (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 validate clinical performance (i.e. estimated sensitivity and specificity) of the T2 Candida test on the T2 DX Instrument compared to blood culture results and/or known Candida positive status of prospectively collected and contrived (i.e. Candida-spiked) clinical specimens.
Detailed description
This study will prospectively collect and analyze whole blood T2 clinical research specimens and concomitant blood culture specimens from patients who have been referred for a blood culture per routine standard of care. Additional analysis of blinded, contrived (i.e. Candida spiked and un-spiked whole blood) specimens will be completed by study sites to augment the analysis of Candida positive blood specimens prospectively obtained from the study population.
The clinical performance of the T2 Candida test on the T2 Dx Instrument will be evaluated by calculating the:
- Estimated clinical specificity of the T2Candida test results compared to Candida negative blood culture results in prospectively collected specimens, and the
- Estimated sensitivity of the T2 Candida test results compared to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to Candida positive blood culture results in prospectively collected clinical specimens.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood culture | – | –Subjects have had a blood culture ordered, per routine standard of care |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who have had a blood culture ordered, per routine standard of care
Key inclusion criteria (3 listed)
- Subject or subject's authorized representative 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 blood culture ordered, per routine standard of care.
- Subject is between 18-95 years of age
Key exclusion criteria (5 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 T2Candida assay with valid results.
- Subject has had an anti-fungal drug administered through the same port or central line as is used to collect the clinical research specimens.
- Treatment of subject with any novel drug compound within 30 days prior to the collection of T2 blood specimens.
- T2 clinical specimen, Tube A contains <3ml of blood.
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
Specificity
Time frame: Up to 19 hours post blood collection
Estimated specificity of the T2Candida test will be examined by comparing T2Candida test results from prospectively collected T2 clinical specimens to blood culture results from specimens that are culture negative for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens.
Sensitivity
Time frame: Up to 19 hours post blood collection
Estimated sensitivity of the T2Candida test will be examined by comparing T2Candida test results to the known Candida positive status or Candida positive blood culture status of contrived specimens that have been spiked at clinically relevant concentrations of the target organisms and, where detected, to blood culture results from specimens that are culture positive for Candida and which have been collected at the same time and from the same anatomical location as the T2 specimens.
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 26 May 2014.
- Derived from this study: PubMed 25586686Mylonakis E, Clancy CJ, Ostrosky-Zeichner L, Garey KW, Alangaden GJ, Vazquez JA, Groeger JS, Judson MA, Vinagre YM, Heard SO, Zervou FN, Zacharioudakis IM, Kontoyiannis DP, Pappas PG. T2 magnetic resonance assay for the rapid diagnosis of candidemia in whole blood: a clinical trial. Clin Infect Dis. 2015 Mar 15;60(6):892-9. doi: 10.1093/cid/ciu959. Epub 2015 Jan 12.
Related trials for Candidemia
RecruitingObservational study
Middle East Study of Infections in Patients With Hematological Malignancies
Hematological Malignancy, Hematopoetic Stem Cell Transplantation
Recruiting
Comparison of Uncomplicated Candidemia Therapy Duration in Children and Adults
Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis
Not yet recruitingObservational study
A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
Candidemia
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.
Peter Pappas, MD principal investigator
University of Alabama at Birmingham
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidemia, run by T2 Biosystems at 8 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 5 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 26 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Specificity (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?
On the ClinicalTrials.gov record for NCT01752166, which also lists 1 linked publication.
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 26 May 2014.