Real World Evidence (RWE, Real World Data), of the Effectiveness of Amoxicillin-Clavulanate in the Treatment of Children with Upper Respiratory Tract Infections (Tonsillitis, Otitis, Sinusitis)

Real-world evidence (RWE) is clinical evidence on a medical product’s safety and efficacy that is generated using real-world data (RWD) resulting from routine healthcare delivery. This study evaluates the clinical efficacy of amoxicillin + clavulanic acid in children with pharyngitis, acute otitis, or acute rhinosinusitis with suspected bacterial origin under normal office and home conditions. Methods: This was a real-life, prospective, observational, pharmacovigilance study. It included children of both sexes between 2 and 12 years old, with a diagnosis of Rhinopharyngitis (tonsillitis), Acute Otitis Media and Rhinosinusitis. The main effectiveness variable evaluated was reduction and time to resolution of symptoms. All patients received Amoxicillin/Clavulanic Acid suspension 600 mg/42.9 mg/5 mL at a dose of 90 mg/Kg/day in two doses, every 12 hours for 7 days. The evaluations were carried out at the beginning, at 72 hours (3rd day) and at 7 days. All patients underwent culture and antibiogram. Results: The majority of cultures were negative for pathogenic germs, suspecting unidentifiable germs, or viral etiology despite the rigorous selection of subjects following validated scores. The most frequently isolated germ was Staphylococcus aureus;growth of gram-negative bacteria was reported in 33.33% of the cultures. There was a significant improvement in symptoms in children with tonsillitis and rhinosinusitis from the first 72 hours of treatment, persisting until the 7 days. In the otitis media group, returning to normal by the tenth day. During the conduction of this investigation, no adverse effects associated with the prescribed therapy were reported.