drugset / Trial / NCT04724044
Anti-inflammatory Action of Oral Clarithromycin in Community-acquired Pneumonia
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
Publications
- Stylianakis E, Kakavoulis N, Foutadakis S, Koufargyris P, Niotis G, Akinosoglou K, Iliopoulou K, Kotsaki A, Chatzopoulos M, Skorda L, Tzavara V, Chrysos G, Gerakari S, Katsaounou P, Kontopoulou T, Dalekos GN, Kumar V, Netea MG, Torres A, Niederman M, Giamarellos-Bourboulis EJ. Molecular pathways driving clarithromycin benefit in community-acquired pneumonia: analysis of the ACCESS randomised trial. EBioMedicine. 2026 May;127:106240. doi: 10.1016/j.ebiom.2026.106240. Epub 2026 Apr 3.
- Giamarellos-Bourboulis EJ, Siampanos A, Bolanou A, Doulou S, Kakavoulis N, Tsiakos K, Katopodis S, Schinas G, Skorda L, Alexiou Z, Armenis K, Katsaounou P, Chrysos G, Masgala A, Poulakou G, Antonakos N, Safarika A, Kyprianou M, Dakou K, Gerakari S, Papanikolaou IC, Milionis H, Marangos M, Dalekos GN, Tzavara V, Akinosoglou K, Hatziaggelaki E, Sympardi S, Kontopoulou T, Mouktaroudi M, Papadopoulos A, Niederman MS. Clarithromycin for early anti-inflammatory responses in community-acquired pneumonia in Greece (ACCESS): a randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2024 Apr;12(4):294-304. doi: 10.1016/S2213-2600(23)00412-5. Epub 2024 Jan 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Clarithromycin | Small molecule | 500 mg | Oral |