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

NCT03345992 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2020-12-22

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Pneumonia
  • Gram-Negative Bacteria Infection
  • Multiple Organ Failure
  • Respiratory Distress Syndrome
  • Mortality
  • Biomarkers

Interventions

DRUG

Clarithromycin

Clarithromycin two vials of lyophilised powder for reconstitution as solution for IV administration per patient, once daily, for four consecutive days.

DRUG

Water for injection

Water for injection 20 ml will be administered, diluted in D/W 5%, IV, once daily for four consecutive days

Sponsors & Collaborators

Principal Investigators

  • Apostolos Armaganidis, 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
2019-09-22
Completion
2020-12-19

Countries

  • Belgium
  • Greece

Study Locations

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Entities

Diseases
Companies

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 NCT03345992 on ClinicalTrials.gov