Azithromycin and Clarithromycin: Clinical and Economic Comparative Study in the Treatment of Acute Otitis Media in Children

Overview

Acute otitis media in children is the most frequent indication in childhood forantibiotics which must be effective against all most frequently occurring bacterial agents and beeconomically acceptable. At the ENT Clinic of the Paediatric Hospital in Brno an open randomizedcomparative study was implemented to compare the use of azithromycin and clarithromycin in thetreatment of this disease. Clinical signs and symptoms were followed up at given time intervals andscored according to a defined pattern. Allocation of patients into groups treated with AZI or CLARIwas done according to a random procedure. AZI was administered in syrup, 10 mg/kg/day, CLARIas a suspension, 15 mg/kg. The study included a total of 100 patients aged 6 months to 12 years, 50were treated with AZI, 50 with CLARI. The clinical outcome at the time of termination of treatment(10th-12th day) was evaluated in 50/50 patients (100%) in the AZI group and in 48/49 (98%) patientsin the CLARI group (p = 0.600). In the AZI group 49 patients (98%) were classified as cured, in theCLARI group 47 (96%) patients. During the subsequent check-up examination (28th-30st day) theclinical outcome was assessed in 49/50 (98%) AZI patients and in 48/49 (98%) CLARI patients. Somepharmacoeconomic data were also assembled. Evaluation of the parents absence from work revealed a significant difference (mean 5.74 in AZI and 9.02 in CLARI, p = 0.0154). The authors evaluatedthe mean cost of antibiotic treatment. In AZI the cost was lower as administration of CLARIsuspension to the older children required two packages. A statistically significant shorter period ofthe parents’ absence from work was recorded in the group on AZI.

Key words:
acute otitis media, children, azithromycin, clarithromycin, comparative study oftreatment of otitis media.