A TRIAL FOR IMMUNOMODULATION IN SEPSIS
- Conditions
- MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestationsA TRIAL FOR IMMUNOMODULATION IN SEPSISTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2017-002171-26-GR
- Lead Sponsor
- Hellenic Institute for the Study of Sepsis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 278
•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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): •Mortality after 90 days<br>•Time to decrease of SOFA score by more than 50%<br>•Time to infection resolution<br>•Duration of hospitalization<br>•Development of secondary infections<br>•Change of cytokine stimulation between days 0 and 4 and between days 0 and 7 <br>•Change of gene expression between days 0 and 7<br>•Change of gut microbiome between days 0 and 7<br>•Epigenetic changes on day 7<br>•Classification of the immune function of screened patients not characterized with MALS neither with hypo-inflammation<br>;Timepoint(s) of evaluation of this end point: 7 days, 90 days