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

NCT04414189 | Completed

• 1 other identifier: INF-06
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sepsis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Arm A

Patients with suspected sepsis at the time of admission to the ICU

Diagnostic Test: HostDx Sepsis

Arm B

Patients not currently suspected but at high risk for sepsis.

Diagnostic Test: HostDx Sepsis

Interventions

HostDx Sepsis DIAGNOSTIC_TEST

Blood collection for mRNA analysis

Arm A; Arm B

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

Subjects admitted to the surgical ICU with suspected sepsis or at high risk for subsequent sepsis onset.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inflammatix: lead
• University of Florida: collaborator

Study Sites (1)

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The blood sample collection materials for the HostDx Sepsis test (PAXgene Blood RNA tubes) will be collected. EDTA tubes for plasma measurements of procalcitonin and IL-6 will be collected. Collection tubes for serum samples to measure viral antibodies and/or viral titers (indicative of reactivation of viral infection) will also be collected. These will be stored locally and processed at a later time point dependent on needs, i.e. suspicion of viral reactivation.

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: June 7, 2020
• Primary Completion: July 21, 2021
• Study Completion: October 19, 2021
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)