Completed study

Official Study Title
A Personalized Randomized Trial of Validation and Restoration of Immune Dysfunction in Severe Infections and Sepsis (PROVIDE)

Brief Description
PROVIDE is a randomized clinical trial aiming to the personalized therapy of patients at septic shock. Using biomarkers, enrolled patients are randomized through a double-dummy approach to immunotherapy or placebo treatment. Immunotherapy could be either anakinra or recombinant human interferon-gamma; enrolment and randomization is based on their laboratory immune profile.

Status: Completed
Study Type: Interventional (Clinical Trial)
Study phase: II
Study sites: 14 sites in Greece
Actual enrolment: 36 participants Identifier: NCT03332225
EudraCT number: 2017-002171-26
National Organization for Medicines Approval: IS075-17
National Ethics Committee Approval: 78/17

Study Start: December 2017
Study Completion: December 2019

Condition/Disease studied: Sepsis; Macrophage Activation Syndrome
Keywords: sepsis; macrophage activation syndrome; immunoparalysis; anakinra; recombinant human interferon-gamma; HLA-DR

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