engleski

Safety and effectiveness of azithromycin in the treatment of respiratory infections in children

Objectives: To describe clinical effectiveness of azithromycin in management of respiratory tract infections in children up to 12 years old, to examine duration of symptoms after beginning the therapy and to mark possible adverse events of treatment with azithromycin. Methods: Overall ITT population included 156 children into the study (65 patients with AP, 27 patients with AS, 32 patients with AOM, and 59 patients with LRTI). Clinical effectiveness was based on results of improvement and cure of the patients after three day treatment with azithromycin, calculating the clinical score for each diagnosis before treatment, at the 4th day (end of the therapy) and at the 12th or 28th day (end of the study). To better estimate patients’ (parents’) satisfaction with treatment diary was given for each child and parents recorded a day when a child felt relief of symptoms. Results: In this study azithromycin led to relief of symptoms after three days in the 89.1% of patients. Antibiotics were prescribed within one year before inclusion in 74.4% of patients and 29.5% were previously treated with macrolides. Clinical effectiveness in ITT population was 94.8% and there were 5.2% failures. Overall, 18 (11.5%) of patients reported twenty five adverse events and 9 AE were characterized as possibly, probably or definitely related to azithromycin. The most common adverse events were diarrhea in 9 (5.8%) patients, vomiting in 6 (3, 8%) and abdominal pain reported in 4(2, 6 %) patients. Conclusion: Results of our study show that azithromycin in treatment of children with respiratory tract infections has high clinical effectiveness and small number of adverse events. However, the major limitation of our study is its design as a noncomparative, observational, postmarketing study and etiology of infections was not confirmed. Despite this, we can conclude that azithromycin is a reliable antibiotic treatment of children’s respiratory tract infections, giving fast resolution of symptoms with little adverse events in patients with presumed bacterial infections.

Azithromycin ; otitis media ; pneumonia ; pharyngitis

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