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.