CandidemiaSTAMPNCT02163889
Serial Therapeutic and Antifungal Monitoring Protocol
An observational study of Candidemia, run by T2 Biosystems at 3 sites in United States.
Trial summary
The objective of this study is to investigate T2Candida performance as a monitoring tool for post-therapy clearance of Candida compared to blood culture. This study will collect a T2clinical specimen and companion blood culture from patients who have exhibited a positive blood culture by gram stain for yeast, and who… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Candidemia
- How many people
- 31 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2014to Apr 2017
- 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: Patients receiving treatment with antifungal therapy for 1 of 5 Candida species: * Candida albicans * Candida tropicalis * Candida glabrata * Candida parapsolosis * Candida krusei
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 is between 18-95 years of age
- Subject has a blood culture result that is positive for yeast within 36 hours of enrollment
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
- All T2 Bio individual clinical research specimens contain < 3 ml of blood
- Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 Bio blood specimens.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama
Birmingham, Alabama, 35294-2030
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
The objective of this study is to investigate T2Candida performance as a monitoring tool for post-therapy clearance of Candida compared to blood culture.
This study will collect a T2clinical specimen and companion blood culture from patients who have exhibited a positive blood culture by gram stain for yeast, and who are receiving treatment with antifungal therapy.
Read the detailed description
One blood culture and one set of T2clinical specimens will be collected at specified intervals to monitor the clearance of Candida infection from the bloodstream.
Each T2 result will be compared to the companion blood culture result. The comparison will determine if the presence of antifungal therapy inhibits blood culture and leads to an incidence of blood culture false negative test results. The T2 result, which is not impacted by the presence of antifungal therapy, can show that the pathogen is still present for some additional period of time.
- Conditions
- Candidemia
- Keywords
- Candida, Blood culture, Antifungal therapy, Sepsis
- 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 blood culture with species identification to be positive for Candida |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to negative test result
The number of days to a negative test result will be compared between the T2Candida Test and blood culture.
Measured: 14 days post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionApr 2017
- Study completionApr 2017
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
- 31 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
- NCT02163889
- Sponsor's protocol ID
- PRO-00254
- Acronym
- STAMP
- Status last verified
- Sep 2015
- First submitted
- 12 Jun 2014
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mylonakis E, Zacharioudakis IM, Clancy CJ, Nguyen MH, Pappas PG. Efficacy of T2 Magnetic Resonance Assay in Monitoring Candidemia after Initiation of Antifungal Therapy: the Serial Therapeutic and Antifungal Monitoring Protocol (STAMP) Trial. J Clin Microbiol. 2018 Mar 26;56(4):e01756-17. doi: 10.1128/JCM.01756-17. Print 2018 Apr.
PubMed 29367293
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Therapeutic and Antifungal Monitoring Protocol
- ClinicalTrials.gov ID
- NCT02163889
- Acronym / sponsor ID
- STAMP / PRO-00254
- Conditions
- Candidemia
- Keywords
- Candida, Blood culture, Antifungal therapy, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- T2 BiosystemsIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 Jun 2014 (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 objective of this study is to investigate T2Candida performance as a monitoring tool for post-therapy clearance of Candida compared to blood culture.
This study will collect a T2clinical specimen and companion blood culture from patients who have exhibited a positive blood culture by gram stain for yeast, and who are receiving treatment with antifungal therapy.
Detailed description
One blood culture and one set of T2clinical specimens will be collected at specified intervals to monitor the clearance of Candida infection from the bloodstream.
Each T2 result will be compared to the companion blood culture result. The comparison will determine if the presence of antifungal therapy inhibits blood culture and leads to an incidence of blood culture false negative test results. The T2 result, which is not impacted by the presence of antifungal therapy, can show that the pathogen is still present for some additional period of time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candida Positive Patients | – | –Symptomatic adult patients, confirmed via blood culture with species identification to be positive for Candida |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving treatment with antifungal therapy for 1 of 5 Candida species: * Candida albicans * Candida tropicalis * Candida glabrata * Candida parapsolosis * Candida krusei
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 is between 18-95 years of age
- Subject has a blood culture result that is positive for yeast within 36 hours of enrollment
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
- All T2 Bio individual clinical research specimens contain < 3 ml of blood
- Use of any novel (i.e. not commercially available) drug compound within 30 days prior to the collection of T2 Bio blood 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
Time to negative test result
Time frame: 14 days post enrollment
The number of days to a negative test result will be compared between the T2Candida Test and 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 20 Aug 2018.
- Derived from this study: PubMed 29367293Mylonakis E, Zacharioudakis IM, Clancy CJ, Nguyen MH, Pappas PG. Efficacy of T2 Magnetic Resonance Assay in Monitoring Candidemia after Initiation of Antifungal Therapy: the Serial Therapeutic and Antifungal Monitoring Protocol (STAMP) Trial. J Clin Microbiol. 2018 Mar 26;56(4):e01756-17. doi: 10.1128/JCM.01756-17. Print 2018 Apr.
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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 Candidemia, 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 20 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?
Time to negative test result (time frame: 14 days post enrollment). 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 NCT02163889, 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 20 Aug 2018.