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Life sciences · Interventional Study
ClinicalTrials.gov · September 28, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Interventional Study.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06637904). This is a study registration, not published results. Lead sponsor: Inflammatix. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 320 participants (ACTUAL). Conditions: Sepsis, Infections, Tachycardia, Fever. Interventions: DIAGNOSTIC_TEST: TriVerity Test. Primary outcome measures: SEP-1 bundle compliance , Within 72 hours of ED admission; Time to final ED disposition order , Date of enrollment (Day 0) to final Follow Up call (up to 35 days). Brief 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.