Fisetin for Sepsis

Phase 2

Recruiting

Led By Michael Puskarich, MD

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 28

Summary

This trial will test if a drug called fisetin helps reduce the risk of sepsis in older people.

Who is the study for?

The STOP-Sepsis trial is for people aged 65 or older who are hospitalized with a primary diagnosis of acute infection and expected to stay at least 48 hours. They must have a certain level of organ dysfunction but not severe kidney failure, very low blood counts, invasive fungal infections, or be in intensive care.

What is being tested?

This study tests different doses of Fisetin against a placebo to see if they can reduce the severity of sepsis in older patients by targeting aging cells. It's set up so that more successful treatments get tested on more patients as the trial goes on.

What are the potential side effects?

Potential side effects aren't specified here, but generally could include allergic reactions to Fisetin, possible interactions with other medications being taken, and typical drug-related risks like nausea or headaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Difference in the composite cardiovascular, respiratory, and renal sequential organ failure assessment (CRR-SOFA)

Secondary study objectives

All-cause mortality

Days in the ICU

Organ failure free days

+7 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Fisetin- dose 2Experimental Treatment1 Intervention

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.

Group II: Fisetin- dose 1Experimental Treatment1 Intervention

Group III: PlaceboPlacebo Group1 Intervention

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.

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