Inflammatix has commenced the TriVerity™ for Improved Management of Emergency Department Patients with Suspected Infections Trial (TIMED), a prospective interventional study designed to evaluate the clinical utility of the TriVerity™ Test in emergency departments (EDs). The trial aims to demonstrate how TriVerity improves the management of patients presenting with suspected acute infection or sepsis, compared to the current standard of care.
The TIMED trial, registered under ClinicalTrials.gov identifier NCT06637904, plans to enroll 600 patients across The Johns Hopkins University (JHU) Medical Center in Baltimore, MD, and OSF HealthCare Saint Francis Medical Center in Peoria, IL. The primary endpoints include compliance with the Severe Sepsis and Septic Shock Management (SEP-1) Bundle, a Centers for Medicare and Medicaid Services (CMS) guideline, and the time to final ED disposition order (admission or discharge).
Trial Design and Objectives
The TIMED trial employs a pre/post-interventional design. Approximately 300 patients will be enrolled in each arm. The pre-intervention arm will utilize retrospective data from patients treated with the standard of care, while the post-intervention arm will involve real-time blood sample analysis via TriVerity. The results from the TriVerity test will then be used to inform treatment decisions based on established guidelines.
Secondary outcomes include the appropriate use of antibiotics and antivirals, ED length of stay, diagnostic ordering practices, hospital admission rates, and total hospital costs. The study is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA).
About the TriVerity Test
The TriVerity Test is performed on the Myrna™ Instrument, Inflammatix's cartridge-based, benchtop analyzer. It measures the expression levels of 29 messenger RNAs (mRNAs) to rapidly assess the body's immune response to infection using machine learning-derived algorithms. The test aims to inform on the presence of infection and the risk of progression to severe illness in adult patients with suspected acute infection or sepsis.
The Myrna Instrument can quantify mRNAs in approximately 30 minutes, requiring minimal operator involvement and maintenance. The TriVerity Test and Myrna Instrument are currently pending FDA clearance and are not available for sale.
Clinical Significance
"For many patients whose presentations are difficult to differentiate, the limitations of existing diagnostics make it extremely challenging to diagnose the presence, type, and severity of infection," said John W. Hafner, MD, emergency medicine physician at OSF HealthCare and co-lead investigator of the TIMED study. "That challenge has multiple ramifications, including suboptimal compliance with the SEP-1 Bundle and lengthy emergency department wait times and stays. The TIMED trial will allow us to evaluate the impact of the novel TriVerity test on these and other important clinical parameters in real time."
Inflammatix's Broader Strategy
Inflammatix is focused on developing diagnostics that rapidly assess a patient's immune system to improve patient care and reduce public health burdens. The company's tests are designed to run on its sample-to-answer isothermal instrument platform, enabling precision medicine at the point of care. The TriVerity test received Breakthrough Device designation from the FDA in November 2023.
