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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: University of Minnesota • ClinicalTrials.gov ID: NCT05758246

Registry updated: 2026-09-01
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Description

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.

Interventions

  • Fisetin-dose 1 (Drug)
    20mg/kg once a day for one day.
  • Fisetin-dose 2 (Drug)
    20mg/kg once a day for two days
  • Placebo (Drug)
    Placebo treatment

Eligibility 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

Conditions

Sepsis Acute Infection Organ Failure

Locations

  • University of Florida — Gainesville, Florida, United States
  • University of Iowa — Iowa City, Iowa, United States
  • Ridges — Burnsville, Minnesota, United States
  • Southdale — Edina, Minnesota, United States
  • M Health Fairview St. John's — Maplewood, Minnesota, United States
  • St. John's — Maplewood, Minnesota, United States
  • University of Minnesota — Minneapolis, Minnesota, United States
  • HCMC — Minneapolis, Minnesota, United States
  • UMMC — Minneapolis, Minnesota, United States
  • University of Mississippi Medical Center — Jackson, Mississippi, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record