World Sepsis Day highlights the urgent need to decrease mortality rates caused by sepsis which is the leading cause of non-cardiac death in U.S. hospitals.
Beaufort, a leading global contract research organization, is providing comprehensive clinical trial services and regulatory affairs for Spectral Medical’s TIGRIS trial, a Phase 3 follow-on study evaluating the use of a Polymyxin B Hemoperfusion device (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.
Beaufort will oversee clinical trial management, data management, biostatistics, quality assurance and regulatory activities to obtain U.S. FDA approval for Spectral’s breakthrough device product to improve the prognosis of U.S. patients diagnosed with sepsis. The PMX cartridge is a therapeutic hemoperfusion device that removes endotoxin from the bloodstream and the use of the PMX device is guided by the Company’s Endotoxin Activity Assay (EAA™), the only FDA cleared diagnostic when used in conjunction with other clinical information and other relevant diagnostic tests aids in the risk assessment of patients in the ICU for progression to severe sepsis. The TIGRIS trial end point is a reduction in the 28-day mortality in subjects with septic shock using the PMX hemoperfusion cartridge and standard of care versus standard of care.
In selecting Beaufort as its CRO, Spectral recognized our extensive Point of Care ICU clinical trial experience…
Sepsis Awareness Month (September) and World Sepsis Day (September 13th) both highlight the critical importance of this clinical trial as sepsis kills 350,000 U.S. adults annually, more than opioid overdoses, breast cancer, and prostate cancer combined. More than 75,000 children in the U.S. are diagnosed with sepsis each year and results in more pediatric deaths than cancer. Sepsis is also the leading cause of non-cardiac death in U.S. hospitals and accounts for 20% of annual global deaths.
In selecting Beaufort as its CRO, Spectral recognized our extensive Point of Care ICU clinical trial experience, which will promote optimized site and patient recruitment, efficient electronic data collection and management, and comprehensive safety reporting and management. Beaufort’s team will provide close coordination with sites and robust quality assessments, ensuring that sites are inspection-ready throughout the study.
In May, Spectral and Beaufort met with Principal Investigators and Clinical Research Coordinators from the TIGRIS trial sites to provide training and educational materials as well as support accelerated patient recruitment and enrollment efforts. Since the meeting, enrollment activities have surged and now align with program milestones. Video footage was also taken during the meeting and will be included in an upcoming Lifetime television program, The Balancing Act, to bring awareness to advancing therapeutic options for sepsis and endotoxic septic shock (ESS).
Watch the Lifetime episode here:
If you are looking for a CRO services partner that can best meet your needs, please contact us to learn about our full range of clinical, regulatory, and quality solutions and how you can benefit from the experience Beaufort provides our diagnostic clients.