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Completed

NCT Number: NCT04414189

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

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

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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

Primary location

University of Florida College of Medicine

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

HostDx Sepsis

Diagnostic Test

Blood collection for mRNA analysis

Primary outcomes

  1. 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.

    Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year

    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

  2. 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.

    Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year

    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

  3. 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.

    Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year

    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

  4. 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.

    Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year

    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

  5. 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.

    Time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year

    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

Sponsors and collaborators

Lead sponsor

Inflammatix

Industry

Collaborators

  • University of Florida

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Dec 22, 2021

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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