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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Minnesota

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.

Eligibility criteria

Qualifiers

Age >=65 years

Primary diagnosis of acute infection (per investigator judgment)

SOFA >1

Admission order to the hospital

Disqualifiers

Admission to the ICU

Vasopressors, mechanical ventilation, or dialysis

Comfort care only

Total bilirubin >3X or AST/ALT >4x upper limit of normal

Trial design

Treatments tested in this trial

  • Fisetin-dose 1
  • Fisetin-dose 2
  • Placebo

Treatment groups

220 Participants
are divided into 3 treatment groups

Locations

10
University of Florida32608, GainesvilleFlorida, United States
University of Iowa52242, Iowa CityIowa, United States
Ridges55337, BurnsvilleMinnesota, United States
Southdale55435, EdinaMinnesota, United States

Sponsors and collaborators

University of Minnesota

Lead sponsor