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

• Status: Not yet recruiting
• Trial end date: 2026-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota

Criteria

Inclusion Criteria:

• Age >=65 years

• Primary diagnosis of acute infection (per investigator judgment)

• SOFA >1

• Admission order to the hospital

• Expected length of stay >=48 hours (per investigator judgment)

Exclusion Criteria:

• Admission to the ICU

• Vasopressors, mechanical ventilation, or dialysis

• Comfort care only

• Total bilirubin >3X or AST/ALT >4x upper limit of normal

• eGFR < 25 ml/ min/ 1.73 m2

• Hemoglobin <7 g/dL; white blood cell count ≤ 2,000/mm3; absolute neutrophil count ≤1 x 10^9/;, or platelet count ≤ 40,000/μL

• Known HIV, Hepatitis B, or Hepatitis C

• Invasive fungal infection (per investigator judgment)

• Uncontrolled effusions or ascites (per investigator judgment)

• New/active invasive cancer except non-melanoma skin cancers

• Known hypersensitivity or allergy to Fisetin.

• Active treatment with potential drug-drug interactions

• Enrolled in another sepsis clinical trial