CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 278 enrolled
Drug / intervention
Tablets +1 moredrug
Likely dose
Clarithromycin 500mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04724044
NCT04724044Phase 3Completed

A Randomized Clinical Trial of Oral Clarithromycin in Community-acquired Pneumonia to Attenuate Inflammatory Responses and Improve Outcomes: the ACCESS Clinical Trial

Hellenic Institute for the Study of Sepsis·interventional·Posted Jan 26, 2021·Updated Dec 12, 2023

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJan 26, 2021
Enrollment StartJan 25, 2021
Primary CompletionApr 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.4 years ago

Interventions

Tabletsdrug

Oral tablets of similar appearance to active study drug

Clarithromycin 500mgdrug

Oral tablets of 500mg of clarithromycin