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Antibiotic treatment of acute and recurrent otitis media in children: an Italian intersociety Consensus

Italian intersociety consensus (SIP et al.) · 2025 · Europe

Source and licence

Authors
Guido Castelli Gattinara, Marcello Bergamini, Giovanni Simeone et al.
Title
Antibiotic treatment of acute and recurrent otitis media in children: an Italian intersociety Consensus
Journal
Italian Journal of Pediatrics, 2025
DOI
10.1186/s13052-025-01894-z
Licence
CC BY 4.0
Changes
Verbatim excerpts; formatting adapted

Full text retrieved 2026-10-27 from Europe PMC · PMC11844117

Licence statement of the original publication

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This page reproduces excerpts of the original publication; the original is authoritative. It has not been reviewed by a physician, does not state a recommendation of Medelix and does not replace medical advice. The guideline may have been updated since.

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Recommendations

Verbatim, with grade of recommendation or strength of consensus where given.

Materials and Methods

  • Recommendation 1For children older than 6 months with AOM: A 'watchful waiting' treatment strategy, where antibiotics are not prescribed immediately (or prescribed with a delay), should be considered and agreed upon with parents to verify the actual need for antimicrobial therapy (Low-moderate quality evidence. Strong recommendation in favour of the intervention). 1.1 For infants younger than 6 months with AOM: immediate antibiotic therapy is recommended due to a lack of safety and efficacy data on the watchful waiting treatment strategy in this age group (Expert opinion. Strong recommendation in favour of the intervention). 1.2 For children aged 6–24 months with bilateral AOM: immediate prescription of antibiotics is recommended, irrespective of severity and except point 1 (Low-quality evidence. Weak recommendation in favour of intervention). 1.3 For children aged 6–24 months with mild unilateral AOM: A watchful waiting strategy should be recommended. (Moderate-quality evidence. Weak recommendation in favour of intervention) 1.4 For children older than 24 months and adolescents with unilateral or bilateral AOM: A watchful waiting strategy is recommended in all cases without comorbidities or risk factors, and considering specific severity conditions requiring immediate treatment. (Moderate-quality evidence. Strong recommendation in favour of intervention). 1.5 For children older than 6 months where watchful waiting is indicated, this strategy is only recommended if follow-up within 72 h is possible and comorbidities are absent.Expert opinion. Strong recommendation in favour of this approach

Recommendation 1

  • 1.1 For infants younger than 6 months with AOM: immediate antibiotic therapy is recommended due to a lack of safety and efficacy data on the watchful waiting treatment strategy in this age groupExpert opinion. Strong recommendation in favour of the intervention
  • 1.2 For children aged 6–24 months with bilateral AOM: immediate prescription of antibiotics is recommended, irrespective of severity and except point 1Low-quality evidence. Weak recommendation in favour of intervention
  • 1.3 For children aged 6–24 months with mild unilateral AOM: A watchful waiting strategy should be recommended.Moderate-quality evidence. Weak recommendation in favour of intervention
  • 1.4 For children older than 24 months and adolescents with unilateral or bilateral AOM: A watchful waiting strategy is recommended in all cases without comorbidities or risk factors, and considering specific severity conditions requiring immediate treatment.Moderate-quality evidence. Strong recommendation in favour of intervention
  • 1.5 For children older than 6 months where watchful waiting is indicated, this strategy is only recommended if follow-up within 72 h is possible and comorbidities are absent.Expert opinion. Strong recommendation in favour of this approach

Recommendations 4

  • 4.1For children requiring antibiotic therapy, amoxicillin or amoxicillin-clavulanate should be administered for 7 or 10 days in high-risk or severe conditions.High quality of evidence. Strong recommendation in favour of intervention

Question 5. Which antibiotic is recommended for children with AOM who do not recover or experience short-term relapse after therapy?

  • 3. at the recommended amoxicillin dose (80-90 mg/kg/day), the clavulanic acid dose is slightly higher than the maximum recommended (11.7 mg/kg/day vs. 10 mg/kg/day)
  • 5. Lower doses of clavulanic acid reduce the incidence of diarrhoea without compromising clinical efficacy.

Materials and Methods

  • Recommendation 6In children and adolescents with recurrent acute otitis media, amoxicillin-clavulanate for 7—10 days is recommended as the first choice for episodes of AOM.Moderate quality of evidence. Weak recommendation in favour of intervention
  • Recommendation 88.1 In patients with AOM/RAOM and a suspected allergy to amoxicillin who have not undergone allergological workup, the selection of alternative antibiotics (such as second/third-generation cephalosporins—cefuroxime or cefpodoxime proxetil) should be guided by meticulous risk stratification.Very low-quality evidence. Expert opinion. Strong recommendation in favour of the intervention. Panel consensus 100%
  • Recommendation 9For uncomplicated AOM, there are no substantial differences in efficacy between routes of administration, so parenteral antibiotics are not recommended.Moderate quality of evidence for penicillin vs. cephalosporins. Strong recommendation against intervention
  • Recommendation 10In the absence of evidence of efficacy and safety, topical antibiotic therapy, in addition to oral antibiotic treatment, is not recommended in children and adolescents with AOM and spontaneous perforated otitis.Very low quality of evidence. Expert opinion. Strong recommendation against intervention
  • Recommendation 11Based on epidemiological data, considering the frequent aetiology from β-lactamase-producing bacteria, the combination of amoxicillin-clavulanic acid should be recommended for cases of severe AOM with spontaneous perforation otorrhea. Amoxicillin-clavulanic acid at a dose of 40 mg/kg/day amoxicillin, supplemented with a plain amoxicillin formulation to ensure optimal doses of amoxicillin (80–90 mg/kg/day in 3 administrations) and clavulanic acid (< 10 mg/Kg/day)Low quality of evidence. Expert opinion. Weak recommendation in favour of intervention

Abstract

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.

Supplementary Information: The online version contains supplementary material available at 10.1186/s13052-025-01894-z.

Contents of the original publication

The section headings of the original.

  • Background
  • Antibiotic therapy
  • Complications of AOM
  • Materials and Methods
  • Questions and recommendation on acute and recurrent acute otitis media
  • Recommendation 1
  • Recommendations 2
  • Recommendations 3.1
  • Recommendations 3.2
  • Recommendations 3.3
  • Recommendations 4
  • Recommendations 5
  • Recommendation 6
  • Recommendations 7
  • Recommendation 8
  • Recommendation 9
  • Recommendation 10
  • Recommendation 11
  • Conclusions

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