NCT05758246

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Acute Infection
• Organ Failure

Interventions

Type	Name	Description
DRUG	Fisetin-dose 1	20mg/kg once a day for one day.
DRUG	Fisetin-dose 2	20mg/kg once a day for two days
DRUG	Placebo	Placebo treatment

Timeline

• Start date: 2023-08-23
• Primary completion: 2026-08-23
• Completion: 2026-08-23
• First posted: 2023-03-07
• Last updated: 2025-10-15

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study