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

• Sponsor: Inflammatix (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04414189
• Collaborator: University of Florida (Other)
• Enrollment: 200
• Location: 1
• Actual Duration (Months): 16.4
• Patients Per Site Per Month: 12.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Diagnostic Test: HostDx Sepsis

Study Design

• Study Type: Observational
• Actual Enrollment: 200 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
• Actual Study Start Date: Jun 7, 2020
• Actual Primary Completion Date: Jul 21, 2021
• Actual Study Completion Date: Oct 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Arm A Patients with suspected sepsis at the time of admission to the ICU	Diagnostic Test: HostDx Sepsis; Blood collection for mRNA analysis
Arm B Patients not currently suspected but at high risk for sepsis.	Diagnostic Test: HostDx Sepsis; Blood collection for mRNA analysis

Outcome Measures

Primary Outcome Measures

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 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 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 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 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 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Arm A

1. Age > 18 years

2. Suspected sepsis at the time of admission to the ICU

3. Direct admission from the ED to the ICU with suspected/proven sepsis.

4. Post-operative ICU admission after sepsis source control procedure

5. Inpatients admitted to the ICU from the ward with suspected sepsis onset.

6. Able to provide subject/proxy informed consent within 96h

Arm B

1. Age > 18 years

2. No suspicion of sepsis at the time of admission to the ICU but at high risk for subsequent sepsis onset

3. Non-trauma admission from the ED to the ICU

4. Post-operative ICU admission

5. Severe trauma admission from the ED (injury severity score >15, hemorrhagic shock, severe traumatic brain injury, and or severe chest trauma)

6. Inpatients admitted to the ICU from the ward for decompensation not initially suspected to be secondary to sepsis.

7. Able to provide subject/proxy informed consent within 96h

Exclusion Criteria:

1. Pre- or post-transplant patients

2. Patients admitted solely for airway monitoring, or vascular/flap check monitoring

3. Previous diagnosis of sepsis on index hospitalization.

4. Unable to provide informed consent within 96h

5. Previously enrolled in the present study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Florida College of Medicine	Gainesville	Florida	United States	32610

Sponsors and Collaborators

• Inflammatix
• University of Florida

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Inflammatix
• ClinicalTrials.gov Identifier: NCT04414189
• Other Study ID Numbers: INF-06
• First Posted: Jun 4, 2020
• Last Update Posted: Dec 22, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Dec 22, 2021