U.S. FDA Approves Spectral's Amended Protocol for its EUPHRATES Trial
News Jun 05, 2014
Spectral Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved the amended protocol for its EUPHRATES trial, reflecting the recommendations of the Data Safety Monitoring Board (DSMB) of April 9, 2014.
The DSMB recommended an additional exclusion criterion be added to the clinical protocol and that the sample size should be increased to 650 patients.
The DSMB recommended that patients with a Multiple Organ Dysfunction Score (MODS) score of ≤ 9 no longer be eligible for randomization in the trial. The MODS score is a recognized scoring system used to evaluate the degree of organ dysfunction which exists in patients with sepsis.
This recommendation is consistent with data from previous PMX trials, which demonstrated that the PMX column is most effective in reducing mortality rates of sicker patients.
"These are very important and positive recommendations for our trial," said Dr. Paul Walker, President and CEO of Spectral. "We believe these refinements in our patient population significantly increase our chances for a positive outcome. The depth of information from our second interim analysis, as was originally planned, has enabled our trial to focus on those patients most likely to benefit from our treatment."
"Our trial has been using the new exclusion criterion since its recommendation on April 9, 2014," stated Debra Foster, Vice President of Clinical Development for Spectral. "Our committed trial sites have incorporated this new exclusion criterion and we are targeting enrolment rates consistent with the timelines we have predicted for the completion of the trial by the end of the first half of 2016. To date, 600 patients have met all clinical inclusion criteria and 283 patients with high endotoxin levels have been randomized into the trial."