How the immune system responds to sepsis and affects long-term health
Official title: A Systems Immunology Approach to Characterize the Immune Response in Sepsis and Its Long-term Complications
Run by Radboud University Medical Center · NCT07273344 · Data updated 2026-11-12
This study will try to identify different immune response types in adults with sepsis by collecting blood samples and tracking their short- and long-term outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, prednisone, immunotherapy |
| Locations | 1 site (Nijmegen, Gelderland) |
| Status | Recruiting |
| Started | November 3, 2025 |
| Main results expected | November 1, 2028 |
| Study ends | December 1, 2028 |
| Registry record updated | August 14, 2026 |
| Trial ID | NCT07273344 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age ≥18) who meet Sepsis-3 criteria (SOFA increase ≥2) and are admitted to intensive or medium care, and who are not chronically immunosuppressed, are ideal candidates.
✕Probably not a fit
Patients with chemotherapy-induced or long-term neutropenia, CD4 counts under 400 cells/µL, primary immunodeficiency, chronic high-dose corticosteroid use, current biologic therapy, or recent solid-organ or allogeneic bone marrow transplant are excluded and unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter prospective observational cohort will enroll about 400 adults with sepsis (Sepsis-3 criteria) admitted to intensive or medium care. Researchers will collect serial blood samples and detailed clinical data without changing patient treatment to measure immune cells, circulating mediators, and epigenetic markers. Patients will be grouped into immunotypes based on these biomarkers and those groups will be correlated with acute outcomes and longer-term morbidity and mortality. The primary goal is biomarker discovery and patient stratification to guide future precision immunotherapies rather than testing an experimental treatment.
Why it matters
Potential benefit: If successful, the findings could help doctors match patients to immune-targeted therapies and reduce organ damage and long-term complications after sepsis.
How similar studies have gone: Previous observational studies have identified immune subtypes in sepsis and linked them to outcomes, but results have been inconsistent and have not yet produced widely used targeted treatments.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18years). * Sepsis 3 criteria: defined as having a suspected or documented infection accompanied by organ dysfunction, represented by a total Sequential Organ Failure Assessment (SOFA-2) score 2 or more for new admissions or as 2 or more point-increase of the total SOFA-2 score for hospitalized patients. Exclusion Criteria: * Known chemotherapy-induced or long-term neutropenia. * Known CD4 counts \<400 cells/µL. * History of primary immunodeficiency * Chronic intake of corticosteroids (defined as total daily dose equal or greater than 0.4 mg/kg of equivalent prednisone for more than the last 15 days). * Current use of biologics. * Solid organ transplant recipients. * Recipients of allogeneic bone marrow transplants.
Where it's running
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Radboud University Medical Center
Nijmegen, Gelderland, Netherlands Recruiting
Study contacts
- Principal investigator: Wouter A. van der Heijden, dr. — Radboud University Medical Center
- Study coordinator: Tristan Couwenbergh
- Email: tristan.couwenbergh@radboudumc.nl
- Phone: +31243618819
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.