Actively Recruiting
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
Led by University of Minnesota · Updated on 2025-10-15
220
Participants Needed
10
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E=�3E65 years
- Primary diagnosis of acute infection as determined by the investigator
- Sequential Organ Failure Assessment (SOFA) score greater than 1
- Admission order to the hospital
- Expected hospital stay of 48 hours or more as judged by the investigator
You will not qualify if you...
- Admission to the intensive care unit (ICU)
- Use of vasopressors, mechanical ventilation, or dialysis
- Receiving comfort care only
- Total bilirubin greater than 3 times the upper limit of normal or AST/ALT greater than 4 times the upper limit of normal
- Estimated glomerular filtration rate (eGFR) less than 25 ml/min/1.73 m2
- Hemoglobin less than 7 g/dL; white blood cell count less than or equal to 2,000/mm3; absolute neutrophil count less than or equal to 1 x 10^9/L; or platelet count less than or equal to 40,000/bcL
- Known HIV, Hepatitis B, or Hepatitis C infection
- Invasive fungal infection as judged by the investigator
- Uncontrolled fluid buildup or ascites as judged by the investigator
- New or active invasive cancer except non-melanoma skin cancers
- Known hypersensitivity or allergy to fisetin
- Currently receiving treatment with drugs that may interact with fisetin
- Enrolled in another sepsis clinical trial
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
2
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
3
Ridges
Burnsville, Minnesota, United States, 55337
Actively Recruiting
4
Southdale
Edina, Minnesota, United States, 55435
Actively Recruiting
5
M Health Fairview St. John's
Maplewood, Minnesota, United States, 55109
Actively Recruiting
6
St. John's
Maplewood, Minnesota, United States, 55109
Actively Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Actively Recruiting
8
HCMC
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
9
UMMC
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
10
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
Research Team
M
Michael Puskarich, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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