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STOP Sepsis

  • Status
    Accepting Candidates
  • Age
    65 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title Senolytics To slOProgression of Sepsis (STOP Sepsis) trial
Protocol number OCR48013
ClinicalTrials.gov ID NCT05758246
Phase Phase 2

Eligibility

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

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.