ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Respiratory Pharmacology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1549014
Efficacy and safety of a new drug formulation, amoxicillin-clavulanate-cineole, for adult lower respiratory tract infections: a nationwide observational study in Morocco
Provisionally accepted
- 1Faculty of Medicine and Pharmacy, Sidi Mohamed Ben Abdellah University, Fez, Fes-Meknes, Morocco
- 2Regional Center of Education and Training Professions of Fes-Meknes, Fez, Morocco
- 3Euromed University, Fez, Fes-Meknes, Morocco
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Background: 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® (amoxicillin-clavulanate-cineole), in adult patients with LRTIs within the community setting.Methods: This observational, non-interventional study recruited 936 patients. Olipen® 500 mg (amoxicillin 500 mg, clavulanate 62.5 mg, cineole 100 mg) was administered as two sachets, three times daily, for 7 to 14 days, as per clinical practice guidelines. The primary outcome focused on the clinical recovery and safety as a secondary outcome.Results: 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 to 4 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® was well tolerated, with most of the adverse events reported were considered non-serious and most of them were resolved (87.5%).Olipen® 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.
Keywords: Lower respiratory tract infections, Community, efficacy, Safety, Olipen®
Received: 20 Dec 2024; Accepted: 14 May 2025.
Copyright: © 2025 BENJELLOUN, EL ACHHAB and nejjari. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Youness EL ACHHAB, Regional Center of Education and Training Professions of Fes-Meknes, Fez, Morocco
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