SepsisNCT04414189
Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
An observational study of Sepsis, run by Inflammatix at 1 site in United States.
Trial summary
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- HostDx Sepsis
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2020to 19 Oct 2021
- 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: Subjects admitted to the surgical ICU with suspected sepsis or at high risk for subsequent sepsis onset.
Who may be able to join
- Arm A
- Age > 18 years
- Suspected sepsis at the time of admission to the ICU
- Direct admission from the ED to the ICU with suspected/proven sepsis.
- Post-operative ICU admission after sepsis source control procedure
- Inpatients admitted to the ICU from the ward with suspected sepsis onset.
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- Able to provide subject/proxy informed consent within 96h
- Arm B
- Age > 18 years
- No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset
- Non-trauma admission from the ED to the ICU
- Post-operative ICU admission
- Severe trauma admission from the ED (injury severity score >15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma)
- Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis.
- Able to provide subject/proxy informed consent within 96h
Who cannot join
- Pre- or post-transplant patients
- Patients admitted solely for airway monitoring, or vascular/flap check monitoring
- Previous diagnosis of sepsis on index hospitalization.
- Unable to provide informed consent within 96h
- Previously enrolled in the present study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida College of Medicine
Gainesville, Florida, 32610
About this study
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU
- Conditions
- Sepsis
- Being tested
- HostDx Sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HostDx SepsisDiagnostic test
Blood collection for mRNA analysis
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Patients with suspected sepsis at the time of admission to the ICU Receives: Diagnostic Test: HostDx Sepsis | |
| Arm B | Patients not currently suspected but at high risk for sepsis. Receives: Diagnostic Test: HostDx Sepsis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Percentage of correctly identified patients with bacterial and/or viral infections using HostDx Sepsis compared to clinical adjudications using routine clinical, laboratory, and other findings
Measured: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (7-day organ support), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
Measured: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (CCI), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
Measured: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (30-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
Measured: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (90-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
Measured: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start7 Jun 2020
- Primary completion21 Jul 2021
- Study completion19 Oct 2021
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inflammatix
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414189
- Sponsor's protocol ID
- INF-06
- Status last verified
- Dec 2021
- First submitted
- 22 May 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
- ClinicalTrials.gov ID
- NCT04414189
- Acronym / sponsor ID
- INF-06
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- InflammatixIndustry (pharma, biotech, devices)
- Collaborators
- University of Florida
- Study start
- 7 Jun 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 4 Jun 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.
This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | – | Diagnostic Test: HostDx SepsisPatients with suspected sepsis at the time of admission to the ICU |
| Arm B | – | Diagnostic Test: HostDx SepsisPatients not currently suspected but at high risk for sepsis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects admitted to the surgical ICU with suspected sepsis or at high risk for subsequent sepsis onset.
Key inclusion criteria (15 listed)
- Arm A
- Age > 18 years
- Suspected sepsis at the time of admission to the ICU
- Direct admission from the ED to the ICU with suspected/proven sepsis.
- Post-operative ICU admission after sepsis source control procedure
Key exclusion criteria (5 listed)
- Pre- or post-transplant patients
- Patients admitted solely for airway monitoring, or vascular/flap check monitoring
- Previous diagnosis of sepsis on index hospitalization.
- Unable to provide informed consent within 96h
- Previously enrolled in the present study.
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 |
|---|---|---|
| HostDx SepsisBlood collection for mRNA analysis | Diagnostic test | Arm A, Arm B |
Primary outcome
Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Percentage of correctly identified patients with bacterial and/or viral infections using HostDx Sepsis compared to clinical adjudications using routine clinical, laboratory, and other findings
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (7-day organ support), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (CCI), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (30-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
Percentage of patients with correctly predicted outcomes using HostDx Sepsis (90-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
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 22 Dec 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Inflammatix at 1 site 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 15 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 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. (time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year). 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 22 Dec 2021.