Safety and Clinical Efficacy of High-dose Amoxicillin/Clavulanic Acid in Children with Acute Respiratory Tract Infections in India: A Multicenter Open-label Non-comparative Phase IV Study

IntroductIonAntimicrobial resistance (AMR) is a global public health concern, primarily attributed to the misuse and overuse of antimicrobials. 1 Community-acquired respiratory tract infections (CA-RTIs) pose a significant global burden and account for substantial antibiotic prescriptions in primary care settings.2,3 The situation is no different in India, where over 4,00,00,000 cases and ~4,000 deaths were reported due to RTIs in 2018.4 A cross-sectional study by Varghese and Muhammad evaluated the prevalence of acute respiratory infections among children under 5 years in India using the National Family Health Survey (2019-2021).According to this study, the prevalence of acute respiratory infections was higher among children aged 0-11 months: 3.4%, followed by those aged 12-23 months: 3.3%, 24-35 months: 2.7%, 36-47 months: 2.5%, and those aged 48-59 months: 2.1%. 5 Additionally, with India being the largest consumer of antibiotics in absolute volume, inappropriate use of antibiotics has been identified as one of the major drivers of AMR in the country.6,7