Status:
COMPLETED
A Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Conditions:
Sepsis
Macrophage Activation Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The aim of the study 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-inflammato...
Detailed Description
Sepsis is a life-threatening organ dysfunction that results from the dysregulated host response to an infection. Accumulating knowledge suggests that this dysregulated host response has a broad spectr...
Eligibility Criteria
Inclusion
- 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 one first-degree relative/spouse in case of patients unable to consent
- Community-acquired pneumonia or hospital-acquired pneumonia or ventilator-associated pneumonia or primary bacteremia or acute cholangitis
- Sepsis defined by the Sepsis-3 definitions.
- Patients with laboratory diagnosis of MALS or hypo-inflammation (immune-paralysis) based on two consecutive blood sampling with 24 hours apart. MALS is defined as the presence of ferritin \>4,420 ng/ml and hypo-inflammation as HLA-DR expression on CD14-monocytes (co-expression) less than 30%
Exclusion
- 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 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
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03332225
Start Date
December 15 2017
End Date
December 31 2019
Last Update
July 29 2020
Active Locations (13)
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1
2nd Department of Critical Care Medicine
Athens, Haidari, Greece, 12462
2
4th Department of Internal Medicine
Athens, Haidari, Greece, 12462
3
Intensive Care Unit, Ioannina University Hospital
Ioannina, Ioannina, Greece, 45500
4
Intensive Care Unit, Center for Accident Rehabilitation (KAT) of Athens
Athens, Kifissia, Greece, 14561