A TRIAL FOR IMMUNOMODULATION IN SEPSIS MedDRA version: 20.0 Level: PT Classification code 10040047 Term: Sepsis System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Kineret
Pharmaceutical Form: Injection
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Intravenous use
Trade Name: Imukin
Pharmaceutical Form: Inject
Sponsors
Hellenic Institute for the Study of Sepsis
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age equal to or above 18 years • Male or female gender • In case of women, unwillingness to remain pregnant during the study period. • Written informed consent provided by the patient or by legal representative 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) or acute cholangitis (AC). • Septic shock defined by the Sepsis-3 definitions. • Patients with either signs of MALS or hypo-inflammation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 78 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: • Age below 18 years • Denial for written informed consent • Acute pyelonephritis or intraabdominal infection other than AC, meningitis or skin infection. It is explicitly stated that in the case of a patient with both AC and any other type of intraabdominal infection, the patient cannot be enrolled. • Any stage IV malignancy • Any do not resuscitate decision • 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 IV 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our aim is to conduct one RCT of personalized immunotherapy in sepsis targeting patients who lie either on the predominantly hyper-inflammatory arm or on the predominantly hypo-inflammatory arm of the spectrum of the host response. These patients will be selected by the use of a panel of biomarkers and laboratory findings and they will be allocated to placebo or immunotherapy treatment according to their needs.;Secondary Objective: Not applicable;Primary end point(s): The primary study endpoint will be the comparative efficacy of the applied immunotherapy versus standard therapy on mortality after 28 days;Timepoint(s) of evaluation of this end point: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mortality after 90 days • Time to decrease of SOFA score by more than 50% • Time to infection resolution • Duration of hospitalization • Development of secondary infections • Change of cytokine stimulation between days 0 and 4 and between days 0 and 7 • Change of gene expression between days 0 and 7 • Change of gut microbiome between days 0 and 7 • Epigenetic changes on day 7 • Classification of the immune function of screened patients not characterized with MALS neither with hypo-inflammation ;Timepoint(s) of evaluation of this end point: 7 days, 90 days | — |
Countries
Greece
Contacts
Public ContactPresident of the Board
Hellenic Institute for the Study of Sepsis
Outcome results
None listed