SepsisNCT07543497
Performance and Impact of the Sepsis ImmunoScore
An observational study of Sepsis, run by Prenosis, Inc..
Trial summary
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Sepsis ImmunoScore
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adults 18 years or older presenting to the hospital or ED, suspected of clinically significant events, including sepsis.
Who may be able to join
- Adult (age 18 years or older) patients presenting to hospitals and emergency departments of medical institutions across the United States.
- Adult (age 18 years or older) patients suspected of sepsis.
Who cannot join
- none
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Utility and Performance of the Sepsis ImmunoScore: A Prospective Cohort Device Study
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
- Conditions
- Sepsis
- Being tested
- Sepsis ImmunoScore
- Keywords
- sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sepsis ImmunoScoreDiagnostic test
The Sepsis ImmunoScore is a risk stratification tool that uses Artificial Intelligence/Machine Learning to aid in the identification of patients likely to have or progress to sepsis within 24 hours of assessment.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients at risk of clinically significant events | Not described | |
| Adult patients suspected of sepsis | Not described Receives: Diagnostic Test: Sepsis ImmunoScore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis diagnosis
meeting sepsis-3 criteria within 24 hours of Sepsis ImmunoScore order
Measured: 24 hours
SEP-1 bundle compliance
proportion of patients meeting SEP-1 bundle criteria for whom all bundle components are delivered within the required time frame
Measured: through study completion, an average of 1 year
Number of clinically significant events such as infection, sepsis, critical care interventions, escalation of care, mortality
(e.g., vasopressor support, renal replacement therapy, non-invasive or invasive respiratory ventilation)
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Time to antibiotic administration
Measured: through study completion, an average of 1 year
Coding compliance including appropriate clinical documentation to justify a diagnosis of sepsis
Measured: through study completion, an average of 1 year
Hospital length of stay
Measured: through study completion, an average of 1 year
ICU length of stay
Measured: through study completion, an average of 1 year
Total charges
Measured: through study completion, an average of 1 year
In-hospital mortality rate
28-day in-hospital mortality rate defined as the proportion of patients with a discharge disposition of "died" prior to 28 days
Measured: through study completion, 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 posted22 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prenosis, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543497
- Sponsor's protocol ID
- CLN-007
- Status last verified
- Apr 2026
- First submitted
- 30 Sep 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility and Performance of the Sepsis ImmunoScore: A Prospective Cohort Device Study
- ClinicalTrials.gov ID
- NCT07543497
- Acronym / sponsor ID
- CLN-007
- Conditions
- Sepsis
- Keywords
- sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Prenosis, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Apr 2026 (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.
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult patients at risk of clinically significant events | – | – |
| Adult patients suspected of sepsis | – | Diagnostic Test: Sepsis ImmunoScore |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults 18 years or older presenting to the hospital or ED, suspected of clinically significant events, including sepsis.
Key inclusion criteria (2 listed)
- Adult (age 18 years or older) patients presenting to hospitals and emergency departments of medical institutions across the United States.
- Adult (age 18 years or older) patients suspected of sepsis.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Sepsis ImmunoScoreThe Sepsis ImmunoScore is a risk stratification tool that uses Artificial Intelligence/Machine Learning to aid in the identification of patients likely to have or progress to sepsis within 24 hours of assessment. | Diagnostic test | Adult patients suspected of sepsis |
Primary outcome
Sepsis diagnosis
Time frame: 24 hours
meeting sepsis-3 criteria within 24 hours of Sepsis ImmunoScore order
SEP-1 bundle compliance
Time frame: through study completion, an average of 1 year
proportion of patients meeting SEP-1 bundle criteria for whom all bundle components are delivered within the required time frame
Number of clinically significant events such as infection, sepsis, critical care interventions, escalation of care, mortality
Time frame: through study completion, an average of 1 year
(e.g., vasopressor support, renal replacement therapy, non-invasive or invasive respiratory ventilation)
6 secondary outcomes
Time to antibiotic administration
Time frame: through study completion, an average of 1 year
Coding compliance including appropriate clinical documentation to justify a diagnosis of sepsis
Time frame: through study completion, an average of 1 year
Hospital length of stay
Time frame: through study completion, an average of 1 year
ICU length of stay
Time frame: through study completion, an average of 1 year
Total charges
Time frame: through study completion, an average of 1 year
In-hospital mortality rate
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Thymosin Alpha 1 and IgM Levels in Sepsis
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Prenosis, Inc..
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: opening soon, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grace Staples ((312) 235-3580, grace.staples@prenosis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis diagnosis (time frame: 24 hours). The study lists 3 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 Apr 2026.