What are the guidelines for diagnosing and treating otitis media (middle ear infection)?

From the Guidelines

Otitis media guidelines recommend a watchful waiting approach for most cases of acute otitis media (AOM) in children over 2 years with mild symptoms, as 80% resolve spontaneously within 2-3 days. For severe cases or children under 2 years, amoxicillin is the first-line antibiotic at 80-90 mg/kg/day divided twice daily for 5-7 days (10 days for severe cases or young children) 1. For penicillin-allergic patients, azithromycin (10 mg/kg on day 1, then 5 mg/kg for 4 days) or clarithromycin (15 mg/kg/day divided twice daily for 10 days) are alternatives. If symptoms worsen after 48-72 hours of observation or don't improve after 3 days of antibiotics, reevaluation is necessary. Pain management with acetaminophen or ibuprofen is important regardless of antibiotic use. For recurrent AOM (3+ episodes in 6 months), consider referral to ENT for possible tympanostomy tubes. Otitis media with effusion (fluid without infection) typically requires no antibiotics and resolves within 3 months in 90% of cases.

Key Considerations

• The diagnosis of AOM should be based on a stringent definition, including symptoms such as otalgia, fever, and signs of middle ear effusion, such as bulging tympanic membrane or limited mobility on pneumatic otoscopy 1.
• The use of tympanostomy tubes is recommended for children with recurrent AOM or persistent OME, especially if there is evidence of hearing loss or speech delay 1.
• Clinicians should counsel families about the natural history of OME, the need for follow-up, and the possible sequelae, such as hearing loss or speech delay 1.
• The management of AOM and OME should be individualized, taking into account the child's age, symptoms, and medical history, as well as the presence of any underlying conditions that may affect the natural course of the disease.

Treatment Options

• Amoxicillin is the first-line antibiotic for AOM, with a dosage of 80-90 mg/kg/day divided twice daily for 5-7 days (10 days for severe cases or young children) 1.
• Alternative antibiotics, such as azithromycin or clarithromycin, may be used in patients with penicillin allergy.
• Pain management with acetaminophen or ibuprofen is important, regardless of antibiotic use.
• Tympanostomy tubes may be considered for children with recurrent AOM or persistent OME, especially if there is evidence of hearing loss or speech delay.

From the FDA Drug Label

The recommended dose of azithromycin for oral suspension for the treatment of pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days or 10 mg/kg as a single dose on the first day followed by 5 mg/kg/day on Days 2 through 5.

For the 366 patients who were evaluated for clinical efficacy at the Day 12 visit, the clinical success rate (i.e., cure plus improvement) was 83% for azithromycin and 88% for the control agent.

For the 362 patients who were evaluated at the Day 24 to 28 visit, the clinical success rate was 74% for azithromycin and 69% for the control agent.

Otitis Media Guidelines:

• The recommended dose of azithromycin for pediatric patients with acute otitis media is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days.
• Clinical success rates for azithromycin in the treatment of acute otitis media were 83% at Day 12 and 74% at Day 24-28.
• The most common side effects were diarrhea/loose stools, vomiting, and rash.
• The incidence of treatment-related adverse events was 10.6% with azithromycin and 20.0% with the control agent 2.

Key Points:

• Azithromycin is effective in the treatment of acute otitis media in pediatric patients.
• The recommended dose is 30 mg/kg given as a single dose or 10 mg/kg once daily for 3 days.
• Clinical success rates are high, with 83% of patients showing improvement at Day 12 and 74% at Day 24-28.
• Common side effects include diarrhea, vomiting, and rash.

From the Research

Otitis Media Guidelines

• The management of acute otitis media (AOM) involves the use of antimicrobial therapy, with high-dose amoxicillin (80-90 mg/kg/day) being a recommended first-line treatment 3, 4.
• For patients who are at high risk for infection with nonsusceptible Streptococcus pneumoniae (NSSP), high-dose amoxicillin may be necessary, but in communities with a low prevalence of NSSP, standard-dose amoxicillin may be sufficient 5.
• Second-line therapy options include high-dose amoxicillin/clavulanate, ceftriaxone, and other cephalosporins, which have demonstrated activity against penicillin-resistant S. pneumoniae and beta-lactamase-producing pathogens 3, 4.
• The pneumococcal conjugate vaccine is recommended for all children less than 2 years old and those at risk for recurrent AOM, such as those in day care or with siblings who have a history of recurrent AOM 3.
• Analgesic treatment, including paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs), is also an important part of AOM management, with paracetamol and ibuprofen being effective in relieving short-term ear pain in children with AOM 6.
• The choice of antimicrobial therapy should be based on factors such as the severity of the infection, the patient's age and medical history, and the local prevalence of resistant organisms 3, 4, 5.
• Tympanocentesis may be useful in identifying the causative pathogen and guiding treatment in patients who have failed multiple courses of antibiotics 3.
• Amoxicillin-clavulanate is considered a suitable treatment option for children with AOM, with a systematic review finding it to be effective in resolving AOM and eradicating Streptococcus pneumoniae from the culture 7.