Performance and Impact of the Sepsis ImmunoScore
- Sponsor
- Prenosis, Inc.
- Study ID
- NCT07543497
- Status
- Not Yet Recruiting
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Conditions
- Sepsis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sepsis ImmunoScore — DIAGNOSTIC_TESTThe 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 Details
The goal of this prospective cohort device study is to assess clinical usage and impact, diagnostic performance, and prognostic performance of the Sepsis ImmunoScore.
Key Dates
- First listed
- Apr 22, 2026
- Start date
- Apr 30, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 5,000 participants (estimated)
Arms
- Arm: Adult patients at risk of clinically significant events
- Arm: Adult patients suspected of sepsis
Primary Outcome Measure
Sepsis diagnosis [ Time Frame: 24 hours ]
Central Contacts
- Grace Staples(312) 235-3580
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