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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 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.

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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.

Conditions Studied

Sepsis Acute Infection Organ Failure

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

FieldValue
Enrollment Target 220 participants
Start Date 2023-08-23
Est. Completion 2026-08-23
Phase Phase 2

Sponsor

University of Minnesota

966 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05758246

The ClinicalTrials.gov registry entry for NCT05758246 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,562-participant average among 90 other Sepsis trials with a reported enrollment target (97% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

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 reports 10 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.