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Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
Sponsor: University of Minnesota
Summary
The long-term goal is to test the clinical efficacy of senolytic therapies to reduce progression to and severity of sepsis in older patients. The central hypothesis is that a threshold burden of SnCs predisposes to a SASP mediated dysfunctional response to PAMPs, contributing to a disproportionate burden of sepsis in older patients. The study hypothesizes timely treatment with fisetin will interrupt this pathway. A multicenter, randomized, adaptive allocation clinical trial to identify the most efficacious dose of the senolytic fisetin to reduce the composite cardiovascular, respiratory, and renal sequential organ failure assessment score at 1 week, and predict the probability of success of a definitive phase III clinical trial.
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2023-08-23
Completion Date
2026-08-23
Last Updated
2025-10-15
Healthy Volunteers
No
Conditions
Interventions
Fisetin-dose 1
20mg/kg once a day for one day.
Fisetin-dose 2
20mg/kg once a day for two days
Placebo
Placebo treatment
Locations (10)
University of Florida
Gainesville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Ridges
Burnsville, Minnesota, United States
Southdale
Edina, Minnesota, United States
M Health Fairview St. John's
Maplewood, Minnesota, United States
St. John's
Maplewood, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
HCMC
Minneapolis, Minnesota, United States
UMMC
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States