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RecruitingSepsisAcute InfectionOrgan Failure

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

Eligible age

65+ yrs

Accepts

All genders

Locations

4 states

Healthy volunteers

No

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About this study

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.

Sponsor: University of Minnesota

You may qualify if…

  • ✓ 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)

You may not qualify if…

  • ✕ 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)

Where it's recruiting

Florida

Gainesville

Iowa

Iowa City

Minnesota

Burnsville · Edina · Maplewood · Minneapolis

Source: ClinicalTrials.gov · NCT05758246 · last updated 2026-09-01