Performance and Impact of the Sepsis ImmunoScore

April 15, 2026 updated by: Prenosis, Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults 18 years or older presenting to the hospital or ED, suspected of clinically significant events, including sepsis.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult patients at risk of clinically significant events
Adult patients suspected of sepsis
Diagnostic test: Sepsis ImmunoScore
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sepsis diagnosis
Time Frame: 24 hours
meeting sepsis-3 criteria within 24 hours of Sepsis ImmunoScore order
24 hours
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
through study completion, an average of 1 year
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)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to antibiotic administration
Time Frame: through study completion, an average of 1 year
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
through study completion, an average of 1 year
Hospital length of stay
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
ICU length of stay
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Total charges
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
In-hospital mortality rate
Time Frame: through study completion, an average of 1 year
28-day in-hospital mortality rate defined as the proportion of patients with a discharge disposition of "died" prior to 28 days
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prenosis, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 30, 2025

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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