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A Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis

NCT03332225 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-07-29

No results posted yet for this study

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-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 randomly allocated to placebo or immunotherapy treatment according to their needs.

Conditions

  • Sepsis
  • Macrophage Activation Syndrome

Interventions

DRUG

Anakinra

Treatment with anakinra

DRUG

Recombinant human interferon-gamma

Treatment with recombinant human interferon-gamma

DRUG

Placebo

Treatment with Placebo

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Antonios Papadopoulos, MD, PhD · National Kapodistrian University of Athens, Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-15
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03332225 on ClinicalTrials.gov