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NCT Number: NCT05758246

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

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.

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Key information

Conditions

Sepsis Acute Infection Infections Inflammation Organ Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA)

    Time frame: day 7

    The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. This outcome assesses only the cardiovascular, respiratory, and renal categories of the total SOFA score, and calculates the change from day 0 to day 7.

Secondary outcomes

  1. Safety of 2 doses of fisetin in patients with mild sepsis

    Time frame: day 28

    Outcome is the number of serious adverse event

  2. Organ failure free days

    Time frame: day 28

    Outcome is 28 days minus the last day the patient required any of the following: ventilator support, vasopressors, or dialysis / renal replacement therapy. Patients who die prior to day 28 are given a value of -1.

  3. Total SOFA score

    Time frame: day 7

    The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.

  4. Zubrod performance status

    Time frame: day 7

    A scale for indicating a patient's functional level: 0 asymptomatic - 1 Symptomatic, fully ambulatory - 2 Symptomatic, in bed - 50% of the day - 3 Symptomatic, in bed; 50% of the day but not bedridden - 4 Bedridden - 5 Dead.

  5. SF-12 score

    Time frame: day 7

    The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual 39;s everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher.

  6. SF-12 score

    Time frame: day 28

    The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual 39;s everyday life. Patients fill out a 12 question survey which is then scored by a clinician or researcher.

  7. Zubrod performance status

    Time frame: day 28

    A scale for indicating a patient's functional level: 0 asymptomatic - 1 Symptomatic, fully ambulatory - 2 Symptomatic, in bed - 50% of the day - 3 Symptomatic, in bed; 50% of the day but not bedridden - 4 Bedridden - 5 Dead.

  8. Days in the ICU

    Time frame: day 28

    This outcome is the number of days the patient was admitted to the ICU.

  9. All-cause mortality

    Time frame: Day 28

    This outcome is the proportion of patients suffering all-cause mortality prior to day 28.

  10. Peripheral CD3+ senescent (SnCs) immune cells

    Time frame: day 7

    Outcome is the relative expression of p16Ink4a in CD3+ cells.

  11. Outcome is the relative expression of p16Ink4a in CD3+ cells.

    Time frame: day 28

    Outcome is the relative expression of p16Ink4a in CD3+ cells.

  12. TNF-alpha

    Time frame: day 7

    Outcome is the concentration of TNF-alpha by Luminex human discovery assay

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Puskarich, MD

CONTACT

[email protected]

612 626 6911

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2023
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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