Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
NCT ID: NCT05758246
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
220 participants
INTERVENTIONAL
2023-08-23
2026-08-23
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Fisetin-dose 1
20mg/kg once a day for one day.
Fisetin- dose 2
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.
Fisetin-dose 2
20mg/kg once a day for two days
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.
Placebo
Placebo treatment
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Michael Puskarich, MD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Florida
Gainesville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Ridges
Burnsville, Minnesota, United States
Southdale
Edina, Minnesota, United States
M Health Fairview St. John's
Maplewood, Minnesota, United States
St. John's
Maplewood, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
HCMC
Minneapolis, Minnesota, United States
UMMC
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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Central Contacts
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Facility Contacts
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David Wacker, PhD
Role: primary
References
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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.
Other Identifiers
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HRP-XXX
Identifier Type: -
Identifier Source: org_study_id
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