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.

BACKGROUND

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.

OBJECTIVE

To compare the efficacy and safety of cefpodoxime and amoxicillin-clavulanate potassium for the treatment of PAOM in children below two years.

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.

CONCLUSIONS

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.