SepsisNCT04529733
Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
A study testing IB10 sphingotest PCT+ in people with Sepsis, run by Nexus DX.
Trial summary
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- IB10 sphingotest PCT+
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 30 Mar 2021
- Phase
- Interventional
- 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
Who may be able to join
- Subject is able and willing to provide written informed consent
- Subject is 18 years of age or older
- Subject is presenting with symptoms suggestive of bacterial infection
- Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):
- Body temperature less than 36°C (96.8°F) or greater than 38°C (100.4°F);
- Heart rate greater than 90 beats per minute;
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- Respiratory rate greater than 20 breaths per minute, or an arterial partial pressure of carbon dioxide (pCO2) less than 4.3 kPa (32 mmHg);
- White blood cell count less than 4,000 cells/mm3 (4 x 109 cells/L) or greater than 12,000 cells/mm3 (12 x 109 cells/L);
- A normal white blood cell count with the presence of greater
- than 10% immature neutrophils.
Who cannot join
- Subjects less than 18 years of age;
- Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above
- Subjects unable or unwilling to provide written informed consent
About this study
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma specimens.
- Conditions
- Sepsis
- Being tested
- IB10 sphingotest PCT+
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IB10 sphingotest PCT+Device
Whole blood in EDTA for procalcitonin POC testing on IB10 sphingotest PCT+ device
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings, with corresponding procalcitonin measurements obtained in a ref or clinical laboratory using a comparative assay, with respect to the same EDTA plasma specimens
Method comparison
Measured: 1 day
To establish the equivalence of IB10 sphingotest PCT+ measurements in EDTA whole blood and plasma specimens, as obtained in point-of-care settings as defined above
Method comparison
Measured: 1 day
To establish equivalence of IB10 sphingotest PCT+ measurements in fresh EDTA plasma specimens and frozen EDTA plasma specimens
in vitro stability
Measured: 24 hours
To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens
Point of Care precision Testing
Measured: 1 day
To establish the in vitro stability of EDTA whole blood and plasma speciments with respect to procalitonin concentrations as measured by the of IB10 sphingotest PCT+ test.
in vitro stability
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start15 Sep 2020 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion30 Mar 2021 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nexus DX
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529733
- Sponsor's protocol ID
- B10-08
- Status last verified
- Aug 2020
- First submitted
- 14 Aug 2020
- Last updated
- 28 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the IB10 Sphingotest PCT+ in a Point-of-Care Setting
- ClinicalTrials.gov ID
- NCT04529733
- Acronym / sponsor ID
- B10-08
- Conditions
- Sepsis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nexus DXIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 30 Mar 2021 (estimated)
- First posted
- 28 Aug 2020 (actual)
- 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.
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings such as emergency rooms or intensive care units, with corresponding procalcitonin measurements obtained in a reference or clinical laboratory using a comparative assay, with respect to the same subset of human EDTA plasma specimens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subject is able and willing to provide written informed consent
- Subject is 18 years of age or older
- Subject is presenting with symptoms suggestive of bacterial infection
- Subject is presenting with two or more of the following symptoms suggestive of systemic inflammatory response syndrome (SIRS):
Key exclusion criteria (3 listed)
- Subjects less than 18 years of age;
- Subjects who do not present with a minimum of two symptoms suggestive of SIRS, as defined above
- Subjects unable or unwilling to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IB10 sphingotest PCT+Whole blood in EDTA for procalcitonin POC testing on IB10 sphingotest PCT+ device | Device | – |
Primary outcome
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings, with corresponding procalcitonin measurements obtained in a ref or clinical laboratory using a comparative assay, with respect to the same EDTA plasma specimens
Time frame: 1 day
Method comparison
To establish the equivalence of IB10 sphingotest PCT+ measurements in EDTA whole blood and plasma specimens, as obtained in point-of-care settings as defined above
Time frame: 1 day
Method comparison
To establish equivalence of IB10 sphingotest PCT+ measurements in fresh EDTA plasma specimens and frozen EDTA plasma specimens
Time frame: 24 hours
in vitro stability
To establish the precision of IB10 sphingotest PCT+ measurements in point-of-care setting with respect to frozen EDTA plasma specimens
Time frame: 1 day
Point of Care precision Testing
To establish the in vitro stability of EDTA whole blood and plasma speciments with respect to procalitonin concentrations as measured by the of IB10 sphingotest PCT+ test.
Time frame: 1 day
in vitro stability
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2020.
- Individual participant dataSharing planned: No
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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?
A study testing IB10 sphingotest PCT+ in people with Sepsis, run by Nexus DX.
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 10 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: status not confirmed, as of the sponsor's last update on 28 Aug 2020. 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?
Results are not available in the source record.
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?
To establish the equivalence of IB10 sphingotest PCT+ measurements in point-of-care settings, with corresponding procalcitonin measurements obtained in a ref or clinical laboratory using a comparative assay, with respect to the same EDTA plasma specimens (time frame: 1 day). The study lists 5 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 28 Aug 2020.