Overview

Personalized Immunotherapy in Sepsis

Status:
Recruiting
Trial end date:
2024-07-28
Target enrollment:
0
Participant gender:
All
Summary
Αim of ImmunoSep is to assess whether personalized adjunctive immunotherapy directed against a state of either fulminant hyper-inflammation or immunoparalysis is able to change sepsis outcomes. Patients will be selected by a panel of biomarkers and laboratory findings and will be allocated to placebo or immunotherapy treatment according to their needs.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Treatments:
Interleukin 1 Receptor Antagonist Protein
Criteria
Inclusion Criteria:

- Age equal to or above 18 years.

- Both genders.

- In case of women, unwillingness to become pregnant during the study period.

- Written informed consent provided by the patient or by one first-degree
relative/spouse in case of patients unable to consent.

- Community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP) or
ventilator-associated pneumonia (VAP) or primary bacteremia (BSI).

- Sepsis defined by the Sepsis-3 definitions. More precisely, sepsis is defined as the
presence of total SOFA (sequential organ failure assessment score) equal to 2 or more
for patients who are admitted with infection at the emergency department OR as any
increase of admission SOFA by 2 or more points for patients already hospitalized.

- Patients with signs of fulminant hyper-inflammation or sepsis-associated
immunoparalysis as defined by ferritin and Quantibrite. Since the state of
hyper-inflammation is considered more life-threatening than the state of
immunoparalysis, patients with lab findings of both immune states are allocated to
treatment targeting hyper-inflammation. It is explicitly stated that patients
diagnosed with novel Coronavirus-2 infection (COVID-19) may participate only in the
fulminant hyper-inflammation arm

- Time from classification into sepsis by the Sepsis-3 definitions and start of blind
intervention less than 72 hours.

Exclusion Criteria:

- Age below 18 years.

- Denial for written informed consent.

- Acute pyelonephritis or intraabdominal infection, meningitis or skin infection.

- Any stage IV malignancy.

- Neutropenia defined as an absolute neutrophil count lower than 1,500/mm3.

- Any 'do not resuscitate' decision in the hospital.

- In the case of BSI, patients with blood cultures growing coagulase-negative
staphylococci or skin commensals or catheter-related infections cannot be enrolled.

- Active tuberculosis (TB) as defined by the co-administration of drugs for the
treatment of TB.

- Infection by the human immunodeficiency virus (HIV).

- Any primary immunodeficiency.

- Oral or intravenous intake of corticosteroids at a daily dose equal or greater than
0.4 mg/kg prednisone or greater the last 15 days.

- Any anti-cytokine biological treatment the last one month.

- Medical history of systemic lupus erythematosus.

- Medical history of multiple sclerosis or any other demyelinating disorder.

- Pregnancy or lactation. Women of child-bearing potential will be screened by a urine
pregnancy test before inclusion in the study.