Recruiting

Phase 2

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

Sponsor:

University of Minnesota

Code:

NCT05758246

Conditions

Sepsis

Acute Infection

Organ Failure

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Fisetin-dose 1

Fisetin-dose 2

Placebo

Study Details

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.

Conditions

Sepsis

Acute Infection

Organ Failure

Study ID

NCT05758246

Start date

Aug 23, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Mar 30, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fisetin- dose 1

Elderly (>=65 years) patients admitted to the hospital with an acute infection and sequential organ failure assessment score sufficient for a diagnosis of sepsis, will be given the first dose of fisetin.

experimental: Fisetin- dose 2

placebo comparator: Placebo

Elderly (>=65 years) patients admitted to the hospital with an acute infection and sequential organ failure assessment score sufficient for a diagnosis of sepsis will receive placebo treatment.

Interventions

Fisetin-dose 1

20mg/kg once a day for one day.

Fisetin-dose 2

20mg/kg once a day for two days

Placebo

Placebo treatment

Primary outcome measure

Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA) [ Time Frame: day 7 ]

Central Contacts and Locations

Central contacts

Michael Puskarich, MD

612 626 6911 mike-em@umn.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Brett A Faine, PharmD

319-310-8067 brett-faine@uiowa.edu

Ridges

Recruiting

Burnsville, Minnesota, United States, 55337

Contacts

Lauren Barrett

barre998@umn.edu

Southdale

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Lauren Barrett

barre998@umn.edu

M Health Fairview St. John's

Recruiting

Maplewood, Minnesota, United States, 55109

St. John's

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Lauren Barrett

barre998@umn.edu

HCMC

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

Audrey Hendrickson

Audrey.Hendrickson@hcmed.org

UMMC

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Lauryn Barrett

barre998@umn.edu

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

James W Galbraith, MD

601-984-5443 jgalbraith@umc.edu

More Information

Sponsor

University of Minnesota

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-01.