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

ClinicalTrials.gov ID

NCT05758246

Lead Sponsor

University of MinnesotaOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

220Estimated

Last Update Posted

Sep 1, 2026Actual

Start Date

Aug 23, 2023Actual

Primary Completion Date

Mar 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

Official Title

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

Brief 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.

• Sepsis
• Acute Infection
• Organ Failure

• Fisetin-dose 1
• Fisetin-dose 2
• Placebo

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Triple

Lead Sponsor

University of MinnesotaOTHER

barre998@umn.edu

barre998@umn.edu

barre998@umn.edu

Audrey.Hendrickson@hcmed.org

barre998@umn.edu

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