Comparison of Efficacy and Safety of Cefpodoxime and Amoxicillin-Clavulanate Potassium in Paediatric Acute Otitis Media in Children below Two Years: A Prospective Longitudinal Study FC01-FC04

摘要

Introduction: Acute Otitis Media (AOM) is one of the frequently diagnosed diseases in children below two years. Amoxicillin-clavulanate potassium is the first line drug in treatment of Paediatric AOM (PAOM). Cefpodoxime has good antimicrobial activity against various types of microorganisms that include causative microorganisms of PAOM.Aim: To compare the efficacy and safety of cefpodoxime and amoxicillin-clavulanate potassium for the treatment of PAOM in children below two years.Materials and Methods: A prospective longitudinal study was conducted on children diagnosed with PAOM. Thirty-six children were included in the study: 17 in the Group A (amoxicillin-clavulanate potassium) and 19 in the Group B (cefpodoxime). Primary outcome of this study was clinical success rate at day 10 visit and secondary outcome was incidence of Adverse Events (AEs).Results: The clinical success rates were 93.8% in Group A and 88.2 % in Group B. These rates are comparable and no statistically significant difference was observed between the groups. Few mild and self-limiting AEs were observed and both the drugs were well tolerated.Conclusion: The results of this prospective study showed that a 10-day course of cefpodoxime is therapeutically comparable to amoxicillin-clavulanate potassium in terms of both efficacy and safety for the treatment of PAOM in children below two years.