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

RECRUITING

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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:

🦠 Sepsis 🦠 Acute Infection 🦠 Organ Failure

🗓️ Study Start (Actual) 23 August 2023

🗓️ Primary Completion (Estimated) 23 August 2026

✅ Study Completion (Estimated) 23 August 2026

👥 Enrollment (Estimated) 220

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Burnsville, Minnesota, United States

📍 Edina, Minnesota, United States

📍 Maplewood, Minnesota, United States

📍 Minneapolis, Minnesota, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 65 Years to N/A (OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 24 February 2023
First Submitted that Met QC Criteria 24 February 2023
First Posted 7 March 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 17 April 2024
Last Update Posted 18 April 2024
Last Verified April 2024