---
title: Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial
nct_id: NCT04414189
overall_status: COMPLETED
sponsor: Inflammatix
study_type: OBSERVATIONAL
primary_condition: Sepsis
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04414189.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04414189"
ct_last_update_post_date: 2021-12-22
last_seen_at: "2026-05-12T06:03:11.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial

**NCT ID:** [NCT04414189](https://clinicaltrials.gov/study/NCT04414189)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Inflammatix
- **Collaborators:** University of Florida
- **Conditions:** Sepsis
- **Start Date:** 2020-06-07
- **Completion Date:** 2021-10-19
- **CT.gov Last Update:** 2021-12-22

## 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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **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.
```

## Arms

- **Arm A** — Patients with suspected sepsis at the time of admission to the ICU
- **Arm B** — Patients not currently suspected but at high risk for sepsis.

## Interventions

- **HostDx Sepsis** (DIAGNOSTIC_TEST) — Blood collection for mRNA analysis

## Primary Outcomes

- **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
- **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
- **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
- **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
- **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

## Locations (1)

- University of Florida College of Medicine, Gainesville, Florida, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of florida college of medicine|gainesville|florida|united states` — added _(2026-05-12)_

---

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