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

Who can join

Ages 65 and older · All sexes

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

About the 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.

What is being tested

• Fisetin-dose 1 (drug)
• Fisetin-dose 2 (drug)
• Placebo (drug)

Sponsor: University of Minnesota · Participants: 220 · Started: Aug 23, 2023

Contact the study team

• Michael Puskarich, MD · Phone: 612 626 6911

Official record on ClinicalTrials.gov — NCT05758246

Locations in the U.S.

Conditions

• Sepsis

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.