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STOP-Sepsis Trial: Fisetin for Sepsis in Older Adults

This study, called STOP-Sepsis, is testing if a drug called Fisetin can help older adults (age 65 and up) with acute infections and early signs of organ failure. Sepsis is a serious condition where the body's response to an infection damages its own tissues and organs. Researchers believe Fisetin might interrupt a specific pathway that contributes to sepsis in older patients. You would receive either Fisetin (one or two doses) or a placebo (an inactive substance). The main goal is to see if Fisetin can reduce the severity of organ damage (heart, lungs, kidneys) after one week. The study is currently recruiting 220 participants.

Study design
This is a multicenter, randomized study, meaning participants are assigned by chance to receive Fisetin or a placebo. It plans to enroll 220 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main outcome is measured at day 7, which suggests follow-up for at least one week after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05758246

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

Recruiting
PHASE2Ages 65+InterventionalTreatment
University of Minnesota
~220 participants
Updated 2025-10-15 on ClinicalTrials.gov
What's tested:Fisetin-dose 1Fisetin-dose 2Placebo

At a glance

Recruiting sites
10 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA)
Measured over day 7

Conditions

Sepsis
Acute Infection
Organ Failure

Explore related trials

Acute infectious diseaseOrgan FailureSepticemia

Where it's being run

10 sites across 4 states
Minnesota7
Florida1
Iowa1
Mississippi1

Study leadership

  • Michael Puskarich, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Michael Puskarich, MD
[email protected]
612 626 6911
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

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