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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414189
• Other study ID #: INF-06
• Status: Completed
• Start date: June 7, 2020
• Est. completion date: October 19, 2021

Study information

• Verified date: December 2021
• Source: Inflammatix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 19, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Diagnostic Test:
• HostDx Sepsis
Blood collection for mRNA analysis

Locations

Country	Name	City	State
United States	University of Florida College of Medicine	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Inflammatix	University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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