SepsisPhase 2NCT05758246

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

A Phase 2 study testing Fisetin-dose 1 and Fisetin-dose 2 in people with Sepsis and Acute Infection, run by University of Minnesota at 10 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Sepsis, Acute Infection, Organ Failure
What is being tested?: Fisetin-dose 1 and Fisetin-dose 2
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 220 participants
Where: 10 sitesUnited States
Study dates: 23 Aug 2023to 30 Jun 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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)

Who cannot join

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

Show all 13Show fewer

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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Puskarich, MD contact

612 626 6911

mike-em@umn.edu

City, postcode or hospital

Sites recruiting now only

10 sites in 1 country

United States10 sites, 8 recruiting

Ridges
Burnsville, Minnesota, 55337
Lauren Barrett, barre998@umn.edu
Recruiting
Southdale
Edina, Minnesota, 55435
Lauren Barrett, barre998@umn.edu
Recruiting
University of Florida
Gainesville, Florida, 32608
Active, not recruiting
University of Iowa
Iowa City, Iowa, 52242
Brett A Faine, PharmD, 319-310-8067, brett-faine@uiowa.edu
Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
James W Galbraith, MD, 601-984-5443, jgalbraith@umc.edu
Recruiting
M Health Fairview St. John's
Maplewood, Minnesota, 55109
David Wacker, PhD
Recruiting
St. John's
Maplewood, Minnesota, 55109
Lauren Barrett, barre998@umn.edu
Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Active, not recruiting
HCMC
Minneapolis, Minnesota, 55415
Audrey Hendrickson, Audrey.Hendrickson@hcmed.org
Recruiting
UMMC
Minneapolis, Minnesota, 55455
Lauryn Barrett, barre998@umn.edu
Recruiting

Other trials in United States

About this study

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
Being tested: Fisetin-dose 1, Fisetin-dose 2, Placebo
Medical subject headings: Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fisetin-dose 1Drug
20mg/kg once a day for one day.
Fisetin-dose 2Drug
20mg/kg once a day for two days
PlaceboDrug
Placebo treatment

Study groups in NCT05758246
Study group	Role	What they receive
Fisetin- dose 1	Experimental	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. Receives: Drug: Fisetin-dose 1
Fisetin- dose 2	Experimental	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 2nd does of fisetin. Receives: Drug: Fisetin-dose 2
Placebo	Placebo comparator	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. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA)
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.
Measured: day 7

Secondary outcomes (12)

Safety of 2 doses of fisetin in patients with mild sepsis
Outcome is the number of serious adverse event
Measured: day 28
Organ failure free days
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.
Measured: day 28
Total SOFA score
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.
Measured: day 7
Zubrod performance status
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.
Measured: day 7
SF-12 score
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.
Measured: day 7
SF-12 score
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.
Measured: day 28
Zubrod performance status
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.
Measured: day 28
Days in the ICU
This outcome is the number of days the patient was admitted to the ICU.
Measured: day 28
All-cause mortality
This outcome is the proportion of patients suffering all-cause mortality prior to day 28.
Measured: Day 28
Peripheral CD3+ senescent (SnCs) immune cells
Outcome is the relative expression of p16Ink4a in CD3+ cells.
Measured: day 7
Outcome is the relative expression of p16Ink4a in CD3+ cells.
Outcome is the relative expression of p16Ink4a in CD3+ cells.
Measured: day 28
TNF-alpha
Outcome is the concentration of TNF-alpha by Luminex human discovery assay
Measured: day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Aug 202330 Jun 2027

First posted7 Mar 2023
Study start23 Aug 2023
Primary completion30 Mar 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
More trials run by University of MinnesotaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will initially be equally randomized between placebo, 20 mg/kg (once), and 20 mg/kg (once daily for 2 days). After 60 participants have been enrolled, the randomization ratio will be adapted so that a higher proportion of participants will be randomized to the optimal dosing regimen. The proportion randomized to the control will be held constant throughout the trial.
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05758246
Sponsor's protocol ID: HRP-XXX
Status last verified: Aug 2026
First submitted: 24 Feb 2023
Last updated: 1 Sep 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Silva M, Wacker DA, Driver BE, Staugaitis A, Niedernhofer LJ, Schmidt EL, Kirkland JL, Tchkonia T, Evans T, Serrano CH, Ventz S, Koopmeiners JS, Puskarich MA; STOP-Sepsis Investigators. Senolytics To slOw Progression of Sepsis (STOP-Sepsis) in elderly patients: Study protocol for a multicenter, randomized, adaptive allocation clinical trial. Trials. 2024 Oct 21;25(1):698. doi: 10.1186/s13063-024-08474-2.
PubMed 39434114

Interested in taking part?

Michael Puskarich, MD

612 626 6911

mike-em@umn.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Sepsis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
ClinicalTrials.gov ID: NCT05758246
Acronym / sponsor ID: HRP-XXX
Conditions: Sepsis, Acute Infection, Organ Failure
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 220 participants (estimated)
Lead sponsor: University of MinnesotaUniversity, hospital or other
Study start: 23 Aug 2023 (actual)
Primary completion: 30 Mar 2027 (estimated)
Study completion: 30 Jun 2027 (estimated)
First posted: 7 Mar 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3
Model description: Participants will initially be equally randomized between placebo, 20 mg/kg (once), and 20 mg/kg (once daily for 2 days). After 60 participants have been enrolled, the randomization ratio will be adapted so that a higher proportion of participants will be randomized to the optimal dosing regimen. The proportion randomized to the control will be held constant throughout the trial.

Arm	Type	Receives
Fisetin- dose 1	Experimental	Drug: Fisetin-dose 1Elderly (>=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.
Fisetin- dose 2	Experimental	Drug: Fisetin-dose 2Elderly (>=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 2nd does of fisetin.
Placebo	Placebo comparator	Drug: PlaceboElderly (>=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.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fisetin-dose 120mg/kg once a day for one day.	Drug	Fisetin- dose 1
Fisetin-dose 220mg/kg once a day for two days	Drug	Fisetin- dose 2
PlaceboPlacebo treatment	Drug	Placebo

Primary outcome

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.

12 secondary outcomes

Safety of 2 doses of fisetin in patients with mild sepsis
Time frame: day 28
Organ failure free days
Time frame: day 28
Total SOFA score
Time frame: day 7
Zubrod performance status
Time frame: day 7
SF-12 score
Time frame: day 7
SF-12 score
Time frame: day 28
Zubrod performance status
Time frame: day 28
Days in the ICU
Time frame: day 28
All-cause mortality
Time frame: Day 28
Peripheral CD3+ senescent (SnCs) immune cells
Time frame: day 7
Outcome is the relative expression of p16Ink4a in CD3+ cells.
Time frame: day 28
TNF-alpha
Time frame: day 7

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
Derived from this study: PubMed 39434114Silva M, Wacker DA, Driver BE, Staugaitis A, Niedernhofer LJ, Schmidt EL, Kirkland JL, Tchkonia T, Evans T, Serrano CH, Ventz S, Koopmeiners JS, Puskarich MA; STOP-Sepsis Investigators. Senolytics To slOw Progression of Sepsis (STOP-Sepsis) in elderly patients: Study protocol for a multicenter, randomized, adaptive allocation clinical trial. Trials. 2024 Oct 21;25(1):698. doi: 10.1186/s13063-024-08474-2.

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RecruitingPhase 4
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Active, not recruitingPhase 4
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Michael Puskarich, MD contact

612 626 6911

mike-em@umn.edu

Michael Puskarich, MD principal investigator

University of Minnesota

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fisetin-dose 1 and Fisetin-dose 2 in people with Sepsis and Acute Infection, run by University of Minnesota at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Puskarich, MD (612 626 6911, mike-em@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA) (time frame: day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05758246, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.