NCT05758246 Senolytics To slOw Progression of Sepsis (STOP-Sepsis) Trial
| NCT ID | NCT05758246 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Minnesota |
| Condition | Sepsis |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2023-08-23 |
| Primary Completion | 2027-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2023-08-23 with a primary completion date of 2027-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age \>=65 years * Primary diagnosis of acute infection (per investigator judgment) * SOFA \>1 * Admission order to the hospital * Expected length of stay \>=48 hours (per investigator judgment) Exclusion Criteria: * Admission to the ICU * Vasopressors, mechanical ventilation, or dialysis * Comfort care only * Total bilirubin \>3X or AST/ALT \>4x upper limit of normal * eGFR \< 25 ml/ min/ 1.73 m2 * Hemoglobin \<7 g/dL; white blood cell count ≤ 2,000/mm3; absolute neutrophil count ≤1 x 10\^9/;, or platelet count ≤ 40,000/μL * Known HIV, Hepatitis B, or Hepatitis C * Invasive fungal infection (per investigator judgment) * Uncontrolled effusions or ascites (per investigator judgment) * New/active invasive cancer except non-melanoma skin cancers * Known hypersensitivity or allergy to Fisetin. * Active treatment with potential drug-drug interactions * Enrolled in another sepsis clinical trial
Contact & Investigator
Michael Puskarich, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05758246 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05758246 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05758246 currently recruiting?
Yes, NCT05758246 is actively recruiting participants. Contact the research team at mike-em@umn.edu for enrollment information.
Where is the NCT05758246 trial being conducted?
This trial is being conducted at Gainesville, United States, Iowa City, United States, Burnsville, United States, Edina, United States and 6 additional locations.
Who is sponsoring the NCT05758246 clinical trial?
NCT05758246 is sponsored by University of Minnesota. The principal investigator is Michael Puskarich, MD at University of Minnesota. The trial plans to enroll 220 participants.