{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T12:15:48Z","timestamp":1784290548937,"version":"3.55.0"},"reference-count":38,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T00:00:00Z","timestamp":1748563200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Pharmacol."],"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Lower respiratory tract infections (LRTIs) remain significant global health threats, causing substantial morbidity and mortality. The treatment landscape for LRTIs has evolved significantly, presenting increasing challenges due to rising antibiotic resistance and frequent treatment failures. This study aims to examine the real-life efficacy and safety of a new drug formulation, Olipen<jats:sup>\u00ae<\/jats:sup> (amoxicillin-clavulanate-cineole), in adult patients with LRTIs within the community setting.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This observational, non-interventional study recruited 936 patients. Olipen<jats:sup>\u00ae<\/jats:sup> 500\u00a0mg (amoxicillin 500\u00a0mg, clavulanate 62.5\u00a0mg, cineole 100\u00a0mg) was administered as two sachets, three times daily, for 7\u201314 days, as per clinical practice guidelines. The primary outcome focused on the clinical recovery and safety as a secondary outcome.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 936 patients were enrolled in the study at the national level. Nearly all patients (94.9%) achieved clinical recovery. Therapeutic failure was reported in 26 patients (2.8%), while the outcome remained undetermined for 22 patients (2.3%). After 3\u20134 days of treatment, 57.8% of patients were symptom-free. Radiologically, 81% of patients showed improvement during follow-up. Treatment effectiveness is not affected patient characteristics, whereas chronic cough and dyspnea may hinder clinical recovery in pa-tients with LTRIs. Olipen<jats:sup>\u00ae<\/jats:sup> was well tolerated, with most of the adverse events reported were considered non-serious and most of them were resolved (87.5%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Olipen<jats:sup>\u00ae<\/jats:sup> was found to be effective and well tolerated in adults with acute exacerbation of chronic bronchitis\/COPD, community-acquired pneumonia or superinfection as well as adult patients with pathological lung.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fphar.2025.1549014","type":"journal-article","created":{"date-parts":[[2025,5,30]],"date-time":"2025-05-30T05:46:51Z","timestamp":1748584011000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of a new drug formulation, amoxicillin-clavulanate-cineole, for adult lower respiratory tract infections: a nationwide observational study in Morocco"],"prefix":"10.3389","volume":"16","author":[{"given":"Mohamed Chakib","family":"Benjelloun","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youness","family":"El Achhab","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chakib","family":"Nejjari","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the ORCA Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2025,5,30]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"1002","DOI":"10.3390\/antibiotics11081002","article-title":"Synergistic action of AMX associated with 1,8-cineole and its effect on the ESBL enzymatic resistance mechanism","volume":"11","author":"Akhmouch","year":"","journal-title":"Antibiotics"},{"key":"B47","doi-asserted-by":"publisher","first-page":"1,294","DOI":"10.3390\/antibiotics11101294","article-title":"The Combination of Amoxicillin and 1, 8-Cineole Improves the Bioavailability and the Therapeutic Effect of Amoxicillin in a Rabbit Model","volume":"11","author":"Akhmouch","year":"","journal-title":"Antibiotics"},{"key":"B2","doi-asserted-by":"publisher","first-page":"113","DOI":"10.1016\/j.ijantimicag.2007.07.037","article-title":"The clinical development and launch of amoxicillin\/clavulanate for the treatment of a range of community-acquired infections","volume":"30","author":"Ball","year":"2007","journal-title":"Int. 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