Antibiotic treatment of acute and recurrent otitis media in children: an Italian intersociety Consensus
Authors: Gattinara Guido Castelli , Bergamini Marcello , Simeone Giovanni , Reggiani Lamberto , Doria Mattia , Ghiglioni Daniele G. , Terminiello Alberto , Cosentino Federica , Cursi Laura , Donà Daniele , Chiappini Elena , Galli Luisa , Vecchio Andrea Lo , Guarino Alfredo , Villani Alberto , Di Mauro Giuseppe , Principi Nicola , Esposito Susanna M. R. , Verga Maria Carmen 
Published: February 2025

Acute Otitis Media (AOM) typically affects previously healthy children and can be recurrent. This inter-society consensus aims to provide evidence-based recommendations for the antibiotic therapy of mild, severe and recurrent otitis media in previously healthy children in Italy.

A systematic literature review was conducted to identify the most recent/relevant evidence. The Embase, Scopus, PubMed, and Cochrane databases were used with the terms "children," "acute otitis media”, “recurrent otitis media”, and "antibiotics," from 2012 to April 2024, with no language restrictions. The review focused on studies conducted in high-income countries involving antibiotic therapy in children over 3 months of age diagnosed with AOM or Recurrent AOM (RAOM). The GRADE ADOLOPMENT was used to assess the possibility of adopting or adapting recommendations from two evidence-based guidelines: 'NICE guideline Otitis media (acute): antimicrobial prescribing', updated to 2022 and SIP Intersocietal GL 2019 “Management of acute otitis media in paediatric age: diagnosis, therapy and prevention” The certainty of the evidence was assessed using the GRADE approach. Final recommendations were formulated through a Delphi consensus process with an expert panel.

All major randomised trials and international guidelines promote the appropriate use of antibiotics and advocate a therapy with narrow-spectrum molecules (amoxicillin). The amoxicillin-clavulanic acid is only envisaged when there is a risk of infection by β-lactamase-producing bacteria. In healthy children, amoxicillin should be initiated as a first-line treatment only after a 48–72-h period of appropriate "watchful waiting", during which symptoms are treated while monitoring the patient clinically to see if symptoms resolve. Amoxicillin-clavulanate or second-generation cephalosporins should be reserved for non-immunized children, those with immune deficiencies or those with underlying conditions. In these cases, the use of a clavulanic acid-protected amoxicillin is preferred even though there is no specific scientific evidence to support this choice.

The recommended amoxicillin dosage is 90 mg/kg/day, divided into three doses, though two doses may be considered to improve compliance. A five-day duration of therapy is advised.

In conclusion the diagnosis of AOM/RAOM relies primarily on clinical assessment, which often introduces uncertainty in distinguishing between viral and bacterial infections whereby there remains significant potential to improve antibiotic utilisation. Future studies could play a key role in enhancing the management of AOM/RAOM in children, ensuring that antibiotic treatments are appropriate and effective.