drugset / Trial / NCT04724044

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

NCT04724044

Phase 3 Completed 278 enrolled Hellenic Institute for the Study of Sepsis
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Clarithromycin Small molecule 500 mg Oral