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 groupsSponsors and collaborators
Source ClinicalTrials.gov