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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Minnesota
Study ID
NCT05758246
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Infection
  • Organ Failure
  • Sepsis

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fisetin-dose 1 — DRUG
    20mg/kg once a day for one day.
  • Fisetin-dose 2 — DRUG
    20mg/kg once a day for two days
  • Placebo — DRUG
    Placebo treatment

Study Details

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.

Key Dates

Start date
Aug 23, 2023
Status verified
Oct 2025
Primary completion
Aug 23, 2026
Completion
Aug 23, 2026

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fisetin- dose 1
    Elderly (\>=65 years) patients admitted to the hospital with an acute infection and sequential organ failure assessment score sufficient for a diagnosis of sepsis, will be given the first dose of fisetin.
  • Experimental: Fisetin- dose 2
    Elderly (\>=65 years) patients admitted to the hospital with an acute infection and sequential organ failure assessment score sufficient for a diagnosis of sepsis, will be given the 2nd does of fisetin.
  • Placebo Comparator: Placebo
    Elderly (\>=65 years) patients admitted to the hospital with an acute infection and sequential organ failure assessment score sufficient for a diagnosis of sepsis will receive placebo treatment.

Primary Outcome Measure

Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA) [ Time Frame: day 7 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32608
Faheem W Guirgis, MD
[email protected]
352-265-5911
University of IowaIowa CityIowa52242
Brett A Faine, PharmD
[email protected]
319-310-8067
RidgesBurnsvilleMinnesota55337
Lauren Barrett
[email protected]
SouthdaleEdinaMinnesota55435
Lauren Barrett
[email protected]
M Health Fairview St. John'sMaplewoodMinnesota55109
David Wacker, PhD
St. John'sMaplewoodMinnesota55109
Lauren Barrett
[email protected]
HCMCMinneapolisMinnesota55415
Audrey Hendrickson
[email protected]
UMMCMinneapolisMinnesota55455
Lauryn Barrett
[email protected]
University of MinnesotaMinneapolisMinnesota55414-
University of Mississippi Medical CenterJacksonMississippi39216
James W Galbraith, MD
[email protected]
601-984-5443

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By research site
University of Florida· Gainesville, FLUniversity of Iowa· Iowa City, IARidges· Burnsville, MNSouthdale· Edina, MNM Health Fairview St. John's· Maplewood, MNSt. John's· Maplewood, MN

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