Overview:
Currently, there exists no method for stratifying pediatric septic shock clinical trial candidates. Specifically, there is no way to eliminate patients that would have a high likelihood of a positive outcome with standard care from these trials. Dr. Wong at Cincinnati Children's Hospital has demonstrated that there is a marked increase in a specific protein in the serum of a non-survivor cohort of septic shock patients. Studies have also established a threshold value for serum levels of this protein, such that patients below this value will likely have a good outcome with respect to septic shock (95% certainty).
The strategy would involve exclusion of patients that would otherwise qualify for trails, except that they have an admission marker serum level below the threshold value. This would improve the risk-to-benefit ratio of the study compound by prospectively eliminating patients that would otherwise have a high likelihood of doing well with stand care.
Recently, Dr. Wong received additional validation of the marker after examining a cohort of patient samples collected by an outside group. The samples from this cohort had their marker serum levels measured using a different method than patients at Cincinnati Children's. The results, however, were remarkably similar to those identified previously. A predictive value for a positive outcome was determined to be 94%.
Applications:
· Stratification of septic shock clinical trials for pediatric, and potentially adult patients
Advantages:
· Excludes patients that would do well without trial compound
· Improves risk-to-benefit ratio of clinical trials
· Easy to measure
· Eliminates unnecessary exposure to trial medications
Patent Information:
Patents Pending
Cincinnati Children's Lead Inventor:
Hector Wong, M.D.