Comparison of the effectiveness and safety of Clarithromycin and Co-Amoxyclav in acute exacerbation of chronic otitis media : a randomized, open-labeled, phase iv clinical trial

Abstract

Objective:To compare the effectiveness and safety of Clarithromycin and co-amoxyclav for the treatment of mild to moderate cases of acute exacerbation of chronic otitis media (AECOM).Materials and methods:Adult patients diagnosed with AECOM were screened and patients fulfilling the inclusion criteria were randomized to receive either Clarithromycin (500 mg) twice daily or co-amoxyclav (625 mg) thrice daily orally for 7 days. The primary outcome of this randomized, open-labeled, phase IV clinical trial was clinical success rate at day 14 visit and the secondary outcome was incidence of adverse events (AES). Fifty patients were enrolled : 25 in the Clarithromycin group and 25 in the co-amoxyclav group.Results :  The clinical success rates were 92.7 % in the Clarithromycin group versus 90.2% in the co-amoxyclav group. These rates are comparable, but no statistically significant difference was observed between the groups.Conclusion:The results of this randomized, open-labeled phase IV clinical trial showed that a 7-day course of Clarithromycin is therapeutically comparable to co-amoxyclav in terms of both clinical effectiveness and safety for the treatment of patients with AECOM.