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Background and purpose: Acute bacterial sinusitis is a very common disease among children. Empirical therapy for acute bacterial sinusitis often includes a 10-14-day period of β-lactamase. Azithromycin, a sustained high tissue level macrolide, due to its pharmacokinetic profile can be used once daily in a shorter treatment course of 3 to 5 days. This study aimed to compare azithromycin and common β-lactamases in treatment of acute bacterial sinusitis. Materials and methods: In this randomized clinical trial study, the population consisted of children aged 1 month to 14 years, referred to a tertiary referral hospital from March to July 2011 with the diagnosis of acute bacterial sinusitis. Patients were divided into three groups randomly based on computer and azithromycin amoxicillin and amoxicillin/clavulanic acid (co-amoxiclav) were prescribed to the group I, II and III, respectively. Signs and symptoms at the days of 2 to 4 and 10 to 14 were evaluated and the collected data were recorded. Results: 155 patients were enrolled with the mean age of 23.23 ± 3.20 months. The response rate was more significant in the group receiving azithromycin compared to other groups (P = 0.0130 and P = 0.0001). On the other hand, the response rate between the two groups receiving amoxicillin and amoxicillin/ clavulanic acid was not significantly different (P = 0.1210). Conclusion: According to this study, further studies need to carry out in order to evaluate azithromycin as a first-line empiric therapy in sinusitis.

Keywords: Azithromycin, amoxicillin, amoxicillin/clavulanic acid, sinusitis

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