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Doctoral Thesis | Pharmacotherapeutics | India | Volume 11 Issue 9, September 2022
Comparison of Efficacy and Safety of Cefpodoxime and Amoxycillin with Clavulanic Acid Combination in Adult Indian Patients with Acute Exacerbation of Chronic Suppurative Otitis Media: A Randomized, Non Interventional, Open-Label, Phase IV Clinical Trial
Dr. Tapash Kumar Kundu | Nina Das | Dr. Sumit Chattopadhyay
Abstract: Introduction: Acute exacerbation of chronic suppurative otitis media (AECSOM) has a high risk of complications, if not treated adequately. Amoxycillin with clavulanic acid combination is often used as primary agent in its treatment. Cefpodoxime has good antimicrobial activity and has been studied for use in paediatric AECSOM, but no head-on comparison study is available between these two medications in adult Indian patients for this indication. Aim: To compare the efficacy and safety of Cefpodoxime and Amoxycillin with clavulanic acid combination for the treatment of AECSOM in adults. Materials and Methods: An open-label, phase IV, non-interventional, prospective, randomzed, observational study was conducted on adults diagnosed with AECSOM. One hundred & twenty adults were included in the study: 60 in each group Group A (Cefpodoxime) and Group B (Amoxycillin with clavulanic acid combination). Primary outcome of this study was clinical success rate at day 14 visit and secondary outcome was incidence of Adverse Events (AEs). Results: The clinical success rates were 98.33% in Group A and 96.66 % in Group B. These rates are comparable, but no statistically significant difference was observed between the groups. The incidence of adverse effects like diarrhoea, nausea and vomiting was more in Amoxycillin with Clavulanic acid combination arm than in the Cefpodoxime arm. Conclusion: The results of this prospective study showed that a 7-days course of Cefpodoxime is therapeutically comparable to Amoxycillin with Clavulanic Acid combination in terms of both clinical effectiveness and safety with lesser adverse effects, for the treatment of patients with AECSOM.
Keywords: Cefpodoxime, Amoxycillin with Clavulanic Acid combination, CSOM, adult patient, India
Edition: Volume 11 Issue 9, September 2022,
Pages: 112 - 116