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NCT06637904 · ClinicalTrials.gov registry record · NA
TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections
A NA study of Sepsis and Infections, sponsored by Inflammatix.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT06637904 is a NA study of Sepsis and Infections that is actively recruiting participants, run by Inflammatix. The registered enrollment target is 300 participants, below the 6,561-participant average among 90 other Sepsis trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06637904, a NA study of Sepsis and Infections, is actively recruiting participants, sponsored by Inflammatix.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study Summary
A pre/post interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and/or the staging area/fast track area) with suspected infection and tachycardia or fever will be enrolled. Study conduct will be performed under an Investigational Device Exemption (IDE) from the Food and Drug Administration (FDA). Participants in the pre-phase, treated with standard of care, will be gathered from a retrospective database using propensity matching, whereas participants in the post-phase will be managed incorporating the TriVerity™ Acute Infection and Sepsis Test results with standardized guidance for interpretation and resulting management actions. Many outcomes will be captured and compared between the pre- and post-phase phases including sepsis bundle compliance, patient disposition, appropriate use of antimicrobials (antibiotics and antivirals) and health economic findings. Safety measures for participants in the post-phase will include patient follow-up at predefined time points. The objective is to demonstrate improvement of patient management when incorporating the TriVerity Test result compared to standard of care. Improvements based on diagnostic (bacterial vs viral vs non-infectious inflammation) and prognostic (need for 7-day ICU level care) readouts of the TriVerity Test result will be tracked.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST TriVerity Test
Study Locations (2)
Illinois
- OSF HealthCare Saint Francis Medical Center - Peoria
Maryland
- Johns Hopkins Department of Emergency Medicine - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2024-11-08 |
| Est. Completion | 2025-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06637904
The ClinicalTrials.gov registry entry for NCT06637904 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,561-participant average among 90 other Sepsis trials with a reported enrollment target (95% lower). The listed sponsor is Inflammatix, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Sepsis appearing as the primary indexed condition, and to 1 intervention - of which TriVerity Test is the first listed.
NCT06637904 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT06637904 about?
NCT06637904 is a clinical study titled "TriVerity™ for Improved Management of Emergency Department (ED) Patients With Suspected Infections". A pre/post interventional use trial, with ED patients who are initially triaged to locations other than a dedicated patient room in the main ED (e.g., waiting room, hallway bed, and/or the staging area/fast track area) with suspected infection and tachycardia or fever will be enrolled. Study conduct...
What is the current status of trial NCT06637904?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2024-11-08. Estimated completion is 2025-03-31.
What conditions does trial NCT06637904 study?
This clinical trial studies the following conditions: Sepsis, Infections, Fever, Tachycardia.
What interventions are being tested in trial NCT06637904?
The interventions under investigation include: TriVerity Test (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06637904?
This trial is sponsored by Inflammatix, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06637904 being conducted?
This trial has 2 study locations across Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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