SepsisNCT01903668
Determination of the Nature of the Endogenous Ligand of TREM-1 and Its Use as a New Diagnostic Biomarker in Sepsis
An observational study of Sepsis, run by Centre Hospitalier Universitaire Dijon.
Trial summary
Step 1: Identification and characterisation of the TREM1L protein from samples already available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods for TREM1L (ELISA or SUPRA MS) Step 4: Validation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Blood samples used for this study come from a collection being created as part of the research entitled "The combined determination STREM-1/PCT/CD64 it allows the diagnosis of sepsis in intensive care" - No. IDRCB 2009 - A00870-57 and led by Professor Sebastian GIBOT CHU Nancy.
Who may be able to join
- patients hospitalised in a Medical Intensive Care unit whatever the reason
- written informed consent obtained
Who cannot join
- patients less than 18 years old or under guardianship, persons without national health insurance.
About this study
Step 1: Identification and characterisation of the TREM1L protein from samples already available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods for TREM1L (ELISA or SUPRA MS) Step 4: Validation of assays for TREM1L and its isoforms in a larger number of subjects (inclusion of samples from Dijon CHU and Besançon CHU)
- Conditions
- Sepsis
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of sTREM-1
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2013 (estimated)
- Study startApr 2012
- Primary completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01903668
- Sponsor's protocol ID
- Ducoroy PHRC IR 2012
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 19 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Nature of the Endogenous Ligand of TREM-1 and Its Use as a New Diagnostic Biomarker in Sepsis
- ClinicalTrials.gov ID
- NCT01903668
- Acronym / sponsor ID
- Ducoroy PHRC IR 2012
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Apr 2014 (estimated)
- First posted
- 19 Jul 2013 (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.
Step 1: Identification and characterisation of the TREM1L protein from samples already available characterised at the hospital Central of Nancy Step 2: Study of the isoforms of TREM1L in correlation with the prognosis of sepsis, Step 3: implementation of assay methods for TREM1L (ELISA or SUPRA MS) Step 4: Validation of assays for TREM1L and its isoforms in a larger number of subjects (inclusion of samples from Dijon CHU and Besançon CHU)
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Blood samples used for this study come from a collection being created as part of the research entitled "The combined determination STREM-1/PCT/CD64 it allows the diagnosis of sepsis in intensive care" - No. IDRCB 2009 - A00870-57 and led by Professor Sebastian GIBOT CHU Nancy.
Key inclusion criteria (2 listed)
- patients hospitalised in a Medical Intensive Care unit whatever the reason
- written informed consent obtained
Key exclusion criteria (1 listed)
- patients less than 18 years old or under guardianship, persons without national health insurance.
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
plasma concentrations of sTREM-1
Time frame: baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2013.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Centre Hospitalier Universitaire Dijon.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
plasma concentrations of sTREM-1 (time frame: baseline). 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 Jul 2013.