At a glance
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A Randomized Clinical Trial of Oral Clarithromycin in Community-acquired Pneumonia to Attenuate Inflammatory Responses and Improve Outcomes: the ACCESS Clinical Trial
In Brief
A Phase 3 clinical trial evaluating Tablets and Clarithromycin 500mg for Community-acquired Pneumonia and 5 related conditions. Completed, enrolled 278 participants across 18 sites.
Detailed 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.
Study Details
Timeline
Interventions
Oral tablets of similar appearance to active study drug
Oral tablets of 500mg of clarithromycin