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A comparative study of azithromycin and amoxycillin in paediatric patients with acute otitis media
E Mohs1, A Rodriguez-Solares, E Rivas
1Hospital Nacional De Niños, San Jose, Costa Rica.
Insights
A three-day azithromycin regimen proved more effective than amoxycillin for treating acute otitis media in children. This antibiotic offered superior clinical outcomes with a similar safety profile, making it a promising option for pediatric ear infections.
Area of Science:
- Pediatric Infectious Diseases
- Pharmacology and Therapeutics
- Otolaryngology
Background:
- Acute otitis media (AOM) is a common childhood infection.
- Amoxicillin is a standard treatment, but resistance and adherence can be issues.
Purpose of the Study:
- To compare the efficacy and safety of a 3-day azithromycin regimen versus a 10-day amoxicillin regimen for AOM in children.
- To evaluate clinical and bacteriological outcomes and assess treatment tolerability.
Main Methods:
- An open-label study involving 154 children aged 2-12 years with clinically diagnosed AOM.
- Patients received either azithromycin (10 mg/kg/day for 3 days) or amoxicillin (30 mg/kg/day for 10 days).
- Clinical, bacteriological, and safety assessments were conducted throughout and after treatment.
Main Results:
- Azithromycin achieved higher cure rates (79%) compared to amoxicillin (58%).
- Excluding recurrent cases, azithromycin demonstrated statistically significant superiority (P = 0.003).
- Both treatments were well-tolerated with a low incidence of mild to moderate gastrointestinal side effects.
Conclusions:
- A 3-day azithromycin regimen is more effective than a 10-day amoxicillin regimen for pediatric acute otitis media.
- Azithromycin offers comparable tolerability to amoxicillin.
- Azithromycin represents a highly effective and well-tolerated therapeutic option for childhood AOM.
Abstract:
In this open study, a three-day regimen of azithromycin (single daily dose of 10 mg/kg) was compared with a ten-day regimen of amoxycillin paediatric suspension (30 mg/kg/day in three divided doses; children > 20 kg received 250 mg tid daily) in 154 children (aged 2-12 years) with a clinical diagnosis of acute otitis media (13 recurrent). Full clinical, bacteriological and laboratory safety assessments were performed during and after the study. Of the 77 azithromycin patients, 61 (79%) were considered cured, 15 (19%) improved and one (1%) failed, compared with 45 (58%) cured, 28 (36%) improved and four (5%) failed among the 77 amoxycillin patients. Excluding from analysis the 13 patients with recurrent otitis media, azithromycin was found to be significantly superior to amoxycillin (P = 0.003). The incidence of side-effects was low, with only two (3%) and three (4%) patients reporting adverse events with azithromycin and amoxycillin, respectively. These were gastrointestinal in nature and of mild or moderate severity, except for one case of severe diarrhoea in the amoxycillin group. No treatment-related abnormalities in the laboratory safety tests were observed, and no patients withdrew from therapy. A three-day regimen of azithromycin was therefore shown to be more effective than, and as well tolerated as, amoxycillin in the treatment of children with acute otitis media.