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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Sepsis, Acute Infection, Organ Failure

In brief

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.

Key facts

Study ID

NCT05758246

Run by

University of Minnesota

People needed

220

Starts

2023-08-23

Expected to finish

2026-08-23

Last updated by the study team

2025-10-15

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University of Florida — Gainesville, Florida, United States (enrolling)
• University of Iowa — Iowa City, Iowa, United States (enrolling)
• Ridges — Burnsville, Minnesota, United States (enrolling)
• Southdale — Edina, Minnesota, United States (enrolling)
• M Health Fairview St. John's — Maplewood, Minnesota, United States (enrolling)
• St. John's — Maplewood, Minnesota, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• HCMC — Minneapolis, Minnesota, United States (enrolling)
• UMMC — Minneapolis, Minnesota, United States (enrolling)
• University of Mississippi Medical Center — Jackson, Mississippi, United States (enrolling)

Full record on ClinicalTrials.gov

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