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Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia

NCT04724044 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2023-12-12

No results posted yet for this study

Summary

Traditional management of community-acquired pneumonia (CAP) relies on the prompt administration of antimicrobials that target the most common causative pathogens. Retrospective analysis of observational clinical studies in CAP showed that the addition of macrolides to standard antibiotic therapy conferred a significant survival benefit. The proposed benefit of macrolides is coming from their anti-inflammatory mode of action. An RCT that proves the attenuation of the high inflammatory burden of the host with CAP after addition of clarithromycin in the treatment regimen is missing. This RCT is aiming to prove that addition of oral clarithromycin to a β-lactam rapidly attenuates the high inflammatory burden of the host in CAP.

Conditions

  • Community-acquired Pneumonia
  • Sepsis
  • Inflammatory Response
  • Mortality
  • Biomarkers
  • SIRS

Interventions

DRUG

Tablets

Oral tablets of similar appearance to active study drug

DRUG

Clarithromycin 500mg

Oral tablets of 500mg of clarithromycin

Sponsors & Collaborators

  • Hellenic Institute for the Study of Sepsis

    lead OTHER

Principal Investigators

  • Evangelos J Giamarellos-Bourboulis, MD, PhD · Hellenic Sepsis Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-25
Primary Completion
2023-04-11
Completion
2023-04-11

Countries

  • Greece

Study Locations

More Related Trials

Entities

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 NCT04724044 on ClinicalTrials.gov