Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial

Study Overview
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Brief Summary
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This study will analyze HostDx Sepsis results from whole blood samples collected from patients with suspected sepsis or at risk for sepsis in the surgical ICU

Official Title
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Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial

Conditions
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Sepsis

Intervention / Treatment
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* Diagnostic Test: HostDx Sepsis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Arm A Age > 18 years Suspected sepsis at the time of admission to the ICU Direct admission from the ED to the ICU with suspected/proven sepsis. Post-operative ICU admission after sepsis source control procedure Inpatients admitted to the ICU from the ward with suspected sepsis onset. Able to provide subject/proxy informed consent within 96h Arm B Age > 18 years No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset Non-trauma admission from the ED to the ICU Post-operative ICU admission Severe trauma admission from the ED (injury severity score >15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma) Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis. Able to provide subject/proxy informed consent within 96h Exclusion Criteria: Pre- or post-transplant patients Patients admitted solely for airway monitoring, or vascular/flap check monitoring Previous diagnosis of sepsis on index hospitalization. Unable to provide informed consent within 96h Previously enrolled in the present study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm A<br>Patients with suspected sepsis at the time of admission to the ICU | Diagnostic Test: HostDx Sepsis<br>* Blood collection for mRNA analysis<br>|
| Arm B<br>Patients not currently suspected but at high risk for sepsis. | Diagnostic Test: HostDx Sepsis<br>* Blood collection for mRNA analysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. | Percentage of correctly identified patients with bacterial and/or viral infections using HostDx Sepsis compared to clinical adjudications using routine clinical, laboratory, and other findings | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year | 
| Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (7-day organ support), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year | 
| Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (CCI), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year | 
| Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (30-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year | 
| Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis. | Percentage of patients with correctly predicted outcomes using HostDx Sepsis (90-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis | Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year |