Performance and Impact of the Sepsis ImmunoScore

NCT07543497 | Not Yet Recruiting FDA Device

• 1 other identifier: CLN-007
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sepsis

Keywords

sepsis

Outcome Measures

Primary Outcomes (3)

• Sepsis diagnosis

  meeting sepsis-3 criteria within 24 hours of Sepsis ImmunoScore order

  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

  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)

  through study completion, an average of 1 year

Secondary Outcomes (6)

• Time to antibiotic administration

  through study completion, an average of 1 year

• Coding compliance including appropriate clinical documentation to justify a diagnosis of sepsis

  through study completion, an average of 1 year

• Hospital length of stay

  through study completion, an average of 1 year

• ICU length of stay

  through study completion, an average of 1 year

• Total charges

  through study completion, an average of 1 year

Study Arms (2)

Adult patients at risk of clinically significant events

Adult patients suspected of sepsis

Diagnostic Test: Sepsis ImmunoScore

Interventions

Sepsis ImmunoScore DIAGNOSTIC_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.

Adult patients suspected of sepsis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Prenosis, Inc.: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Remnant volume of samples drawn for routine clinical care.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Grace Staples

CONTACT

(312) 235-3580; grace.staples@prenosis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: April 22, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share