Overview

Benefit of Clarithromycin in Patients With Severe Infections Through Modulation of the Immune System

Status:
Completed
Trial end date:
2020-12-19
Target enrollment:
Participant gender:
Summary
High mortality associated with sepsis and Multiple Organ Dysfunction Syndrome (MODS) calls for alternative, individualized therapies in selected patients that might benefit form specific interventions. Role of macrolides as potential immunomodulatory treatment in sepsis is promising, but unclear. Subgroup analysis of previous large-scale clinical trials on patients with ventilator-associated pneumonia or gram-negative sepsis, showed that addition of clarithromycin to standard antibiotic therapy conferred a significant survival benefit in the subgroup of patients with respiratory dysfunction and MODS. The INCLASS study is aiming to assess the efficacy of intravenous treatment of clarithromycin in the reduction of 28-day mortality among patients suffering from these entities.
Phase:
Phase 3
Details
Lead Sponsor:
Hellenic Institute for the Study of Sepsis
Collaborator:
European Commission
Treatments:
Clarithromycin