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

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.

Conditions

Sepsis, Acute Infection, Organ Failure

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Sepsis
Intervention / Treatment

-

Contacts and Locations

Burnsville

Ridges, Burnsville, Minnesota, United States, 55337

Edina

Southdale, Edina, Minnesota, United States, 55435

Maplewood

M Health Fairview St. John's, Maplewood, Minnesota, United States, 55109

Maplewood

St. John's, Maplewood, Minnesota, United States, 55109

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55414

Minneapolis

HCMC, Minneapolis, Minnesota, United States, 55415

Minneapolis

UMMC, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Michael Puskarich, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2026-08-23