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

Objectives: To describe clinical effectiveness of azithromycin in the management of respiratory tract infections in children up to 12 years of age; to examine duration of symptoms after commencement of therapy and to mark adverse events possibly caused by treatment with azithromycin.

Methods: The overall ITT population included 156 children (65 with acute pharyngitis/tonsillitis (AP), 32 with acute otitis media (AOM), and 59 with lower respiratory tract infections (LRTI)). Clinical effectiveness was based on results of improvement and cure after 3 day's 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, a diary was provided for each child and parents recorded the days when a child felt relief of symptoms.

Results: In this study azithromycin led to relief of symptoms after 3 days in 89.1% of patients. Antibiotics had been prescribed within 1 year prior to inclusion in 74.4% of patients and 29.5% had previously been treated with macrolides. Clinical effectiveness in the intention-to-treat (ITT) population was 94.8% and there were 5.2% failures. Overall, 18 (11.5%) patients reported 25 adverse events (AEs) and nine AEs were characterized as possibly, probably or definitely related to azithromycin. The most common adverse events were diarrhea in nine (5.8%) cases, vomiting in six (3.8%) and abdominal pain reported in four (2.6 %) patients.

Conclusion: Results of this study show that azithromycin in the treatment of children with respiratory tract infections has high clinical effectiveness and a small number of adverse events. However, major limitations of the study are its design as a non-comparative, observational, postmarketing study and that the etiology of infections was not confirmed. Despite this, it can be concluded that azithromycin is a reliable antibiotic treatment for children's respiratory tract infections, giving fast resolution of symptoms with few adverse events in patients with presumed bacterial infections.