CandidemiaDIRECTNCT01525095
Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)
An observational study of Candidemia, run by T2 Biosystems at 5 sites in United States.
Trial summary
The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Candidemia
- How many people
- 700 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2012to Mar 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 undergone a diagnostic blood culture.
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.
- For Group A,
- Males and females 18 - 95 years of age.
- Subject is confirmed to have fungemia as evidenced by a positive diagnostic blood culture and subsequent species identification.
- For Group B,
- Males and females 18 - 95 years of age.
- Subject is hospitalized with a medical problem other than fungemia, or is being treated as an outpatient for some non-infection-related condition, and
- Subject is confirmed to not have fungemia as evidenced by diagnostic blood culture and subsequent species identification.
Who cannot join
- Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0006
Henry Ford Hospital
Detroit, Michigan, 48202
University of Houston College of Pharmacy
Houston, Texas, 77030
University of Kentucky
Lexington, Kentucky, 40536-0298
University of California San Francisco
San Francisco, California, 94110
About this study
Official title: Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)
The purpose of this study is to assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.
- Conditions
- Candidemia
- Keywords
- Candida, Diagnostic Assay, Blood culture, Sepsis, T2 Magnetic Relaxation
- Medical subject headings
- Candidemia, Torulopsis, Sepsis
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 |
|---|---|---|
| Candida Positive Patients | Symptomatic adult patients, confirmed via concordant diagnostic blood culture and species identification and subsequent second blood culture results and species identification that are Candida positive | |
| Candida Negative Patients | Hospitalized adult patients, confirmed via concordant diagnostic blood culture with subsequent species identification and subsequent second blood culture with subsequent species identification that are Candida negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Candida Positive patients
Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal
Measured: 3-5 days post blood culture
Secondary outcomes (1)
Number of Candida Negative Patients
Number of Candida Negative patients based on concordant, sequential blood culture results and a negative T2 signal
Measured: 3-5 days post blood culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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-control
- Time perspective
- Prospective
- Enrolment
- 700 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
- NCT01525095
- Sponsor's protocol ID
- PRO-00030
- Acronym
- DIRECT
- Status last verified
- Jun 2014
- First submitted
- 25 Jan 2012
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Clancy CJ, Pappas PG, Vazquez J, Judson MA, Kontoyiannis DP, Thompson GR 3rd, Garey KW, Reboli A, Greenberg RN, Apewokin S, Lyon GM 3rd, Ostrosky-Zeichner L, Wu AHB, Tobin E, Nguyen MH, Caliendo AM. Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel. Clin Infect Dis. 2018 May 17;66(11):1678-1686. doi: 10.1093/cid/cix1095.
PubMed 29438475Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.
PubMed 23315320
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Infections Rapidly and Easily for Candidemia Trial (DIRECT)-Part 1 (Prospective Collection and Freezing of Whole Blood Specimens)
- ClinicalTrials.gov ID
- NCT01525095
- Acronym / sponsor ID
- DIRECT / PRO-00030
- Conditions
- Candidemia
- Keywords
- Candida, Diagnostic Assay, Blood culture, Sepsis, T2 Magnetic Relaxation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- T2 BiosystemsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 2 Feb 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 assure the uniform collection, handling, storage and transport of patient whole blood specimens and associated information to support validation of the T2 Candida Assay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candida Positive Patients | – | –Symptomatic adult patients, confirmed via concordant diagnostic blood culture and species identification and subsequent second blood culture results and species identification that are Candida positive |
| Candida Negative Patients | – | –Hospitalized adult patients, confirmed via concordant diagnostic blood culture with subsequent species identification and subsequent second blood culture with subsequent species identification that are Candida negative |
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 undergone a diagnostic blood culture.
Key inclusion criteria (8 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.
- For Group A,
- For Group B,
Key exclusion criteria (2 listed)
- Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 blood specimens.
- 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.
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
Number of Candida Positive patients
Time frame: 3-5 days post blood culture
Number of Candida Positive patients based on concordant, sequential blood culture results and a positive T2 signal
1 secondary outcome
Number of Candida Negative Patients
Time frame: 3-5 days post blood culture
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 9 Jun 2014.
- Derived from this study: PubMed 29438475Clancy CJ, Pappas PG, Vazquez J, Judson MA, Kontoyiannis DP, Thompson GR 3rd, Garey KW, Reboli A, Greenberg RN, Apewokin S, Lyon GM 3rd, Ostrosky-Zeichner L, Wu AHB, Tobin E, Nguyen MH, Caliendo AM. Detecting Infections Rapidly and Easily for Candidemia Trial, Part 2 (DIRECT2): A Prospective, Multicenter Study of the T2Candida Panel. Clin Infect Dis. 2018 May 17;66(11):1678-1686. doi: 10.1093/cid/cix1095.
- Derived from this study: PubMed 23315320Clancy CJ, Nguyen MH. Finding the "missing 50%" of invasive candidiasis: how nonculture diagnostics will improve understanding of disease spectrum and transform patient care. Clin Infect Dis. 2013 May;56(9):1284-92. doi: 10.1093/cid/cit006. Epub 2013 Jan 11.
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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.
Peter Pappas, MD principal investigator
University of Alabama at Birmingham
5 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 5 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 8 inclusion and 2 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 9 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Number of Candida Positive patients (time frame: 3-5 days post blood culture). 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 NCT01525095, which also lists 2 linked publications.
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 9 Jun 2014.