Role of Transposable Elements in Septic Immune Aging (SITE)

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Sepsis, Severe; Sepsis and Septic Shock; Sepsis at Intensive Care Unit; Sepsis, Septic Shock; Sepsis, Severe Sepsis and Septic Shock; Sepsis With Multiple Organ Dysfunction (MOD); Sepsis With Acute Organ Dysfunction
• Intervention / Treatment: Genetic: RNA and DNA Sequencing

• Study Type: Observational
• Enrollment (Estimated): 116

Contacts and Locations

• Study Contact: Name: Alexendar R Perez, M.D., Ph.D; Phone Number: 415-476-1000; Email: Alexendar.Perez@ucsf.edu
• Study Contact Backup: Name: Matthieu Legrand, M.D., Ph.D; Phone Number: 415-476-1000; Email: matthieu.legrand@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Alexendar R Perez, M.D., Ph.D; Phone Number: 415-476-1000; Email: Alexendar.Perez@ucsf.edu
      • Contact: Matthieu Legrand, M.D., Ph.D; Phone Number: 415-476-1000; Email: matthieu.legrand@ucsf.edu
      • Principal Investigator: Alexendar R Perez, M.D., Ph.D
      • Principal Investigator: Judith Hellman, M.D.
      • Principal Investigator: Matthieu Legrand, M.D., Ph.D
      • Sub-Investigator: Elizabeth Whitlock, M.D.
      • Sub-Investigator: Orestes Mavrothalassitis, M.D.
      • Sub-Investigator: Joana Vidigal, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study population includes adult patients admitted to the intensive care unit with sepsis with a SOFA score of at least 2. Sepsis is defined by the Sepsis 3 Criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Sepsis; Adult patients (age 18 and older) admitted to the intensive care unit (ICU) meeting Sepsis 3 Criteria.	Genetic: RNA and DNA Sequencing; DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.
Healthy Individual Controls; Healthy individuals not admitted to the hospital.	Genetic: RNA and DNA Sequencing; DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Immune Aging	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality (30-day)	30 days
Secondary Infection	30 days

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alexendar R Perez, M.D., Ph.D, University of California, San Francisco; Principal Investigator: Judith Hellman, M.D., University of California, San Francisco; Principal Investigator: Matthieu Legrand, M.D., Ph.D, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2025
• Primary Completion (Estimated): February 14, 2028
• Study Completion (Estimated): August 14, 2028

Study Registration Dates

• First Submitted: January 30, 2025
• First Submitted That Met QC Criteria: January 30, 2025
• First Posted (Actual): February 5, 2025

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Sepsis; Mortality; Secondary Infections; Transposable Elements; Immune Aging; Critical Care Medicine (ICU)
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic; Coinfection; Investigative Techniques; Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Genetic Techniques; Sequence Analysis; RNA; Sequence Analysis, DNA
• Other Study ID Numbers: 23-39420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No