SepsisSITENCT06809868
Role of Transposable Elements in Septic Immune Aging
An observational study of Sepsis and Sepsis and Septic Shock, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Sepsis and Septic Shock, Sepsis With Multiple Organ Dysfunction (MOD)
- What is being tested?
- RNA and DNA Sequencing
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2025to 14 Aug 2028
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 or older
- Admitted to ICU with sepsis (Sepsis 3 Criteria)
- SOFA score of at least 2 at time of enrollment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Alexendar R Perez, M.D., Ph.D, 415-476-1000, Alexendar.Perez@ucsf.edu
Matthieu Legrand, M.D., Ph.D, 415-476-1000, matthieu.legrand@ucsf.edu
About this study
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:
- Do transposable elements prematurely age the immune systems of patients with sepsis?
- Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?
- 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.
- Conditions
- Sepsis, Sepsis and Septic Shock, Sepsis With Multiple Organ Dysfunction (MOD), Sepsis With Acute Organ Dysfunction, Sepsis, Severe, Sepsis at Intensive Care Unit
- Being tested
- RNA and DNA Sequencing
- Keywords
- Sepsis, Transposable Elements, Immune Aging, Mortality, Secondary Infections, Critical Care Medicine (ICU)
- Medical subject headings
- Sepsis, Shock, Septic, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RNA and DNA SequencingGenetic
DNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Sepsis | Adult patients (age 18 and older) admitted to the intensive care unit (ICU) meeting Sepsis 3 Criteria. Receives: Genetic: RNA and DNA Sequencing | |
| Healthy Individual Controls | Healthy individuals not admitted to the hospital. Receives: Genetic: RNA and DNA Sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Aging
Measured: 6 weeks
Secondary outcomes (2)
Mortality (30-day)
Measured: 30 days
Secondary Infection
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start14 Feb 2025
- Primary completion14 Feb 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alexendar R Perez, M.D., Ph.D, Principal investigator, University of California, San FranciscoJudith Hellman, M.D., Principal investigator, University of California, San FranciscoMatthieu Legrand, M.D., Ph.D, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06809868
- Sponsor's protocol ID
- 23-39420
- Acronym
- SITE
- Status last verified
- Jan 2026
- First submitted
- 30 Jan 2025
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Transposable Elements in Septic Immune Aging
- ClinicalTrials.gov ID
- NCT06809868
- Acronym / sponsor ID
- SITE / 23-39420
- Conditions
- Sepsis, Sepsis and Septic Shock, Sepsis With Multiple Organ Dysfunction (MOD), Sepsis With Acute Organ Dysfunction, Sepsis, Severe, Sepsis at Intensive Care Unit
- Keywords
- Sepsis, Transposable Elements, Immune Aging, Mortality, Secondary Infections, Critical Care Medicine (ICU)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 14 Feb 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 5 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Do transposable elements prematurely age the immune systems of patients with sepsis?
- Do transposable elements correlate with increased mortality in patients with sepsis in the ICU?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Sepsis | – | Genetic: RNA and DNA SequencingAdult patients (age 18 and older) admitted to the intensive care unit (ICU) meeting Sepsis 3 Criteria. |
| Healthy Individual Controls | – | Genetic: RNA and DNA SequencingHealthy individuals not admitted to the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 or older
- Admitted to ICU with sepsis (Sepsis 3 Criteria)
- SOFA score of at least 2 at time of enrollment
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RNA and DNA SequencingDNA and RNA sequencing will be conducted on both control participants and patients with sepsis who are admitted to the ICU. | Genetic | Healthy Individual Controls, Patients with Sepsis |
Primary outcome
Immune Aging
Time frame: 6 weeks
2 secondary outcomes
Mortality (30-day)
Time frame: 30 days
Secondary Infection
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexendar R Perez, M.D., Ph.D principal investigator
University of California, San Francisco
Judith Hellman, M.D. principal investigator
University of California, San Francisco
Matthieu Legrand, M.D., Ph.D principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Sepsis and Septic Shock, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexendar R Perez, M.D., Ph.D (415-476-1000, Alexendar.Perez@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune Aging (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.