Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fisetin-dose 1, Fisetin-dose 2, Placebo.
- Who it may be relevant to
- Registry conditions: Sepsis, Acute Infection, Organ Failure. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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
Primary outcome measures
- Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA) [Time frame: day 7]
Secondary outcome measures (12)
- Safety of 2 doses of fisetin in patients with mild sepsis [Time frame: day 28]
- Organ failure free days [Time frame: day 28]
- Total SOFA score [Time frame: day 7]
- Zubrod performance status [Time frame: day 7]
- SF-12 score [Time frame: day 7]
- SF-12 score [Time frame: day 28]
- Zubrod performance status [Time frame: day 28]
- Days in the ICU [Time frame: day 28]
- All-cause mortality [Time frame: Day 28]
- Peripheral CD3+ senescent (SnCs) immune cells [Time frame: day 7]
- Outcome is the relative expression of p16Ink4a in CD3+ cells. [Time frame: day 28]
- TNF-alpha [Time frame: day 7]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 10 centers
- University of Florida — Gainesville
- University of Iowa — Iowa City
- Ridges — Burnsville
- Southdale — Edina
- M Health Fairview St. John's — Maplewood
- St. John's — Maplewood
- University of Minnesota — Minneapolis
- HCMC — Minneapolis
- … and 2 more centers
Publications
- Silva M, Wacker DA, Driver BE, Staugaitis A, Niedernhofer LJ, Schmidt EL, Kirkland JL, Tchkonia T, Evans T, Serrano CH, Ventz S, Koopmeiners JS, Puskarich MA; STOP-Sepsis Investigators. Senolytics To slOw Progression of Sepsis (STOP-Sepsis) in elderly patients: Study protocol for a multicenter, randomized, adaptive allocation clinical trial. Trials. 2024 Oct 21;25(1):698. doi: 10.1186/s13063-024-0 PMID 39434114
Identifiers
NCT: NCT05758246 · HRP-XXX