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NCT Number: NCT07543497

Performance and Impact of the Sepsis ImmunoScore

The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Sepsis diagnosis

    Time frame: 24 hours

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

  2. 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

  3. 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)

Secondary outcomes

  1. Time to antibiotic administration

    Time frame: through study completion, an average of 1 year

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

    Time frame: through study completion, an average of 1 year

  3. Hospital length of stay

    Time frame: through study completion, an average of 1 year

  4. ICU length of stay

    Time frame: through study completion, an average of 1 year

  5. Total charges

    Time frame: through study completion, an average of 1 year

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Staples

CONTACT

[email protected]

(312) 235-3580

Sponsors and collaborators

Lead sponsor

Prenosis, Inc.

Industry

Registry information

Official study title

Clinical Utility and Performance of the Sepsis ImmunoScore: A Prospective Cohort Device Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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