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RECRUITINGPhase 2INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Fisetin-dose 1

20mg/kg once a day for one day.

DRUG

Fisetin-dose 2

20mg/kg once a day for two days

DRUG

Placebo

Placebo treatment

Locations (10)

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