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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Aug 23, 2026 → Mar 30, 2027
See other at-risk trials from University of Minnesota

Record History

  1. Primary completion pushed from Aug 23, 2026 to Mar 30, 2027
    • Study completion pushed from Aug 23, 2026 to Jun 30, 2027
    • Site details revised at 2 of 10 sites
    v11
  2. Site details revised at 3 of 10 sitesv10
  3. Study sites: 7 to 10v9
  4. Site contacts updated at 1 of 7 sitesv8
  5. Study sites: 6 to 7v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 1 to 6v6
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Primary and study completion dates: Aug 17, 2026 to Aug 23, 2026
    • Start date changed from estimate of Aug 17, 2023 to Aug 23, 2023
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Start date: Jun 1, 2023 to Aug 17, 2023
    • Primary and study completion dates: Jun 1, 2026 to Aug 17, 2026
    v3
  5. Start date: Apr 1, 2023 to Jun 1, 2023
    • Primary and study completion dates: Apr 1, 2026 to Jun 1, 2026
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05758246
Lead Sponsor University of Minnesota
Conditions
(from sponsor)		 Sepsis, Acute Infection, Organ Failure
Related terms Sepsis
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov