Otitis media is a middle ear infection which can exist in an acute or chronic state. The condition may or may not manifest any symptoms. Bacteria or viruses are the aetiological agents. The majority of children suffer from acute otitis media (AOM) once by the age of 3 years, but some of them may even experience six or more recurrences before the age of 3 years.

Amoxicillin and other beta-lactam antibiotics that have been considered standard drugs for the treatment of otitis media are becoming less effective due to the emergence of resistance. Bacteria and viruses are the aetiological microorganisms causing otitis media, and beta-lactams are effective against bacteria only. However, Azithromycin possesses antiviral, antibacterial, as well as anti-inflammatory activity. 

A clinical study was conducted in order to evaluate the efficacy and safety of Azithromycin and Amoxicillin/Clavulanate for treating otitis media in children.

• The efficacy evaluation of both these drugs was based on clinical or bacteriological efficacy. The efficacy of Azithromycin was comparable to that of Amoxicillin/Clavulanate. 
• Azithromycin was found to be safer and more tolerable by children compared to Amoxicillin/Clavulanate. 
• The clinical adverse events found in both Azithromycin and Amoxicillin/Clavulanate-treated groups were similar. The most common clinical adverse events observed in both treatment groups were gastrointestinal problems such as diarrhoea, vomiting, nausea, and abdominal cramp.

Therefore, Azithromycin can be considered a drug of choice for treating otitis media in children.