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NCT05758246 · ClinicalTrials.gov registry record · Phase 2
Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
A Phase 2 study of Sepsis and Acute Infection, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 220
- Enrollment target
- 10
- Study locations
NCT05758246: Recruiting Phase 2 study of Sepsis and Acute Infection, sponsored by University of Minnesota.
NCT05758246 is a Phase 2 study of Sepsis and Acute Infection that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 220 participants, below the 6,562-participant average among 90 other Sepsis trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05758246, a Phase 2 study of Sepsis and Acute Infection, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 220 participants
- Enrollment target
- 10
- Study locations
Study Summary
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.
Primary Outcome
The Sequential Organ Failure Assessment (SOFA) score is a scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category. This outcome assesses only the cardiovascular, respiratory, and renal categories of the total SOFA score, and calculates the change from day 0 to day 7.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fisetin-dose 1
- DRUG Fisetin-dose 2
Study Locations (10)
Minnesota
- Ridges - Burnsville
- Southdale - Edina
- M Health Fairview St. John's - Maplewood
- St. John's - Maplewood
- University of Minnesota - Minneapolis
- HCMC - Minneapolis
- UMMC - Minneapolis
Florida
- University of Florida - Gainesville
Iowa
- University of Iowa - Iowa City
Mississippi
- University of Mississippi Medical Center - Jackson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2023-08-23 |
| Est. Completion | 2026-08-23 |
| Phase | Phase 2 |
What NCT05758246 shows while recruiting
NCT05758246 is an interventional study that assigns participants to a tested intervention. The registered 220 participants enrollment target is mid-sized for trials with a published cap, below the 6,562-participant average among 90 other Sepsis trials with a reported enrollment target (97% lower).
The record links to 3 conditions, with Sepsis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05758246 lists 10 locations in 4 states (Minnesota, Florida, Iowa).
Frequently Asked Questions
What is clinical trial NCT05758246 about?
NCT05758246 is a clinical study titled "Senolytics To slOw Progression of Sepsis (STOP-Sepsis) 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 b...
What is the current status of trial NCT05758246?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 220 participants. The study started on 2023-08-23. Estimated completion is 2026-08-23.
What conditions does trial NCT05758246 study?
This clinical trial studies the following conditions: Sepsis, Acute Infection, Organ Failure.
What interventions are being tested in trial NCT05758246?
The interventions under investigation include: Placebo (DRUG), Fisetin-dose 1 (DRUG), Fisetin-dose 2 (DRUG).
Who is sponsoring clinical trial NCT05758246?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05758246 being conducted?
This trial has 10 study locations across Florida, Iowa, Minnesota, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sepsis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05758246's enrollment target sits among peer trials
220 39th of 90 higher than 52 of 90 other Sepsis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sepsis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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