Using fisetin to slow down sepsis in older patients
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
This study is testing whether a treatment called fisetin can help older patients with sepsis feel better and prevent their condition from getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 10 sites (Gainesville, Florida and 9 other locations) |
| Trial ID | NCT05758246 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 65 and above who are hospitalized with an acute infection and have a SOFA score greater than 1.
Not a fit: Patients who are critically ill and require ICU admission, or those with severe comorbidities or active cancer, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for older patients suffering from sepsis by reducing organ failure and enhancing recovery.
How similar studies have performed: While the approach of using senolytics in sepsis is relatively novel, preliminary studies have shown promise in targeting senescent cells to improve health outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida and 9 other locations
- University of Florida — Gainesville, Florida, United States (Recruiting)
- 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)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Hcmc — Minneapolis, Minnesota, United States (Recruiting)
- Ummc — Minneapolis, Minnesota, United States (Recruiting)
- University of Mississippi Medical Center — Jackson, Mississippi, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.