Evaluating the Use of Polymyxin B Hemoperfusion in a Randomized controlled trial of Adults Treated for Endotoxemia and Septic Shock
EUPHRATES is a randomized, double-blind controlled, clinical trial that compares standard of care versus standard of care and Toraymyxin, directed by Spectral’s EAA™ Endotoxin Activity Assay. The target population is critically ill patients with septic shock and endotoxemia (as measured by the EAA™). The trial is expected to enroll approximately 650 patients at 50 sites throughout the U.S. and Canada, and will have a primary end point of 28 day mortality.
Spectral’s EUPHRATES trial is the world’s first theranostics trial conducted in the area of sepsis. Theranostics, a combination diagnostic and therapeutic, is a relatively new way of approaching patient care for sepsis. The power of theranostics is the ability to direct a treatment that is appropriate and personalized for a specific patient. In Spectral’s EUPHRATES trial, the EAA™ will be used to determine the level of endotoxin in the bloodstream of a patient with septic shock, and if EAA™ is elevated (≥ 0.6 EAA™ units) the patient is eligible to be randomized to Toraymyxin plus standard of care or, standard of care alone.
The EUPHRATES trial brings The Company a step closer to providing U.S. patients the opportunity to access this unique therapeutic device. Toraymyxin has been used safely on more than 100,000 patients worldwide, guided by the EAA™ diagnostic, has the potential to address a large unmet medical need. In keeping with the concept of personalized medicine, Toraymyxin use, guided by the EAA™, allows physicians to target patients most likely to benefit.
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