Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial

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.

NCT Number	NCT05758246
Lead Sponsor	University of Minnesota
Conditions	Sepsis, Acute Infection, Organ Failure
Enrollment	220 participants
Start Date	2023-08-23
Primary Completion	2026-08-23 (estimated)
Study Completion	2026-08-23 (estimated)
Updated on ClinicalTrials.gov	2025-10-15