Using fisetin to slow down sepsis in older patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of senolytic therapy, specifically fisetin, in reducing the severity and progression of sepsis in older patients aged 65 and above. It is a multicenter, randomized, adaptive allocation trial that will test different doses of fisetin against a placebo. The primary outcome measure will be the change in the sequential organ failure assessment score at one week, which will help predict the success of a future definitive phase III trial. The study is designed to identify the optimal dose of fisetin that can interrupt the pathway leading to sepsis-related organ failure.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Iowa
  Iowa City, Iowa, United States Recruiting
• Ridges
  Burnsville, Minnesota, United States Recruiting
• Southdale
  Edina, Minnesota, United States Recruiting
• M Health Fairview St. John's
  Maplewood, Minnesota, United States Recruiting
• St. John's
  Maplewood, Minnesota, United States Recruiting
• Hcmc
  Minneapolis, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Michael Puskarich, MD — University of Minnesota
• Study coordinator: Michael Puskarich, MD
• Email: mike-em@umn.edu
• Phone: 612 626 6911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.