Completed study
Official Study Title
A double-blind, randomized, placebo-controlled clinical study of the efficacy of INtravenous CLArithromycin as adjunctive treatment in patients with Sepsis and respiratory and multiple organ dysfunction Syndrome
Brief Description
INCLASS is a randomized clinical trial aiming to compare the efficacy of intravenous clarithromycin over placebo in patients with sepsis and respiratory failure.
Details
Status: Completed
Study Type: Interventional (Clinical Trial)
Study phase: III
Study sites: 12 (9 sites in Greece, 3 sites in Belgium)
Actual enrolment: 110 participants
ClinicalTrials.gov Identifier: NCT03345992
EudraCT number: 2017-001056-55
National Organization for Medicines Approval: IS 60-17
National Ethics Committee Approval: 64/17
Study Start: December 2017
Study Completion: December 2020
Condition/Disease studied: Sepsis; Pneumonia; Gram-Negative Bacteria Infection; Multiple Organ Failure; Respiratory Distress Syndrome; Mortality; Biomarkers
Keywords: Macrolides
Related publications
- Effect of intravenous clarithromycin in patients with sepsis, respiratory and multiple organ dysfunction syndrome: a randomized clinical trial
Critical Care 2022 Jun 18;26(1):183 - Differential response induced by LPS and MPLA in immunocompetent and septic individuals
Clinical Immunology 2021 May;226:108714