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NCT Number: NCT06809868

Role of Transposable Elements in Septic Immune Aging

The goal of this observational study is to learn about how transposable element levels affect the patient outcomes in sepsis. The main questions it aims to answer is:

1. Do transposable elements prematurely age the immune systems of patients with sepsis? 2. Do transposable elements correlate with increased mortality in patients with sepsis in the ICU? 3. Do transposable elements correlate with increased amount of secondary infections in patients with sepsis in the ICU?

Participants will have blood drawn from them but will not be subjected to additional interventions.

Recruiting

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Key information

Conditions

Sepsis Coinfection Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis With Acute Organ Dysfunction Sepsis With Multiple Organ Dysfunction (MOD) Sepsis and Septic Shock Sepsis at Intensive Care Unit Sepsis, Septic Shock Sepsis, Severe Sepsis, Severe Sepsis and Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location status: Recruiting

Location contact

Alexendar R Perez, M.D., Ph.D

CONTACT

[email protected]

415-476-1000

Alexendar R Perez, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

Elizabeth Whitlock, M.D.

SUB_INVESTIGATOR

Joana Vidigal, Ph.D

SUB_INVESTIGATOR

Judith Hellman, M.D.

PRINCIPAL_INVESTIGATOR

Matthieu Legrand, M.D., Ph.D

CONTACT

[email protected]

415-476-1000

Matthieu Legrand, M.D., Ph.D

PRINCIPAL_INVESTIGATOR

Orestes Mavrothalassitis, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or older
  • Admitted to ICU with sepsis (Sepsis 3 Criteria)
  • SOFA score of at least 2 at time of enrollment

Exclusion criteria

  • Patients on organ transplantation immunosuppression
  • Patients with preexisting leukopenia
  • Cancer patients receiving CAR-T therapy
  • Patients who are under 18 years of age or otherwise deemed pediatric
  • Patients with an ongoing bleeding diathesis (ie: DIC, hemorrhagic shock)
  • Patients with a chronic hemoglobin below 7.0
  • Patients who, prior to their ICU admission, are blood transfusion dependent

Treatment and study plan

RNA and DNA Sequencing

Genetic

DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.

Primary outcomes

  1. Immune Aging

    Time frame: 6 weeks

Secondary outcomes

  1. Mortality (30-day)

    Time frame: 30 days

  2. Secondary Infection

    Time frame: 30 days

Study contacts

Contact information is provided by the study sponsor or research team.

Alexendar R Perez, M.D., Ph.D

CONTACT

[email protected]

415-476-1000

Matthieu Legrand, M.D., Ph.D

CONTACT

[email protected]

415-476-1000

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Acronym: SITE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 5, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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