Banking heavily on APACHE III
By Karen Bernstein
The physician who devised the modified APACHE III method of prospectively defining patients who will benefit from sepsis drugs hopes that the system will become the "common language" of sepsis trials, permitting comparison of future trials and allowing clinicians to consider the efficacy of cocktails of drugs.
William Knaus, director of the ICU research unit at the George Washington Medical Center in Washington, D.C., led a team of researchers that devised an APACHE III prognostic system specific to sepsis patients. The team applied the entry criteria for Synergen Inc.'s Phase III Antril IL-1ra trial to a database of 60,000 critically ill patients and came up with 1,200 patients who met the criteria, Knaus told BioCentury.
Importance to SYGN
"We found out what each factor was and built a model of patient characteristics at entry that influence the outcome," he said. Thus, in contrast to other companies' entry criteria for new Phase III trials, which have been based on retrospective analyses of patients in earlier trials, Knaus said his model was independently reached ahead of time based on a separate patient group.