How should acute otitis media be evaluated and managed in children (6 months–12 years) and adults, including first‑line antibiotic choice and dosing, alternatives for penicillin allergy, treatment of severe infection, and criteria for observation versus immediate therapy?

Acute Otitis Media: Evaluation and Management

Diagnostic Criteria

Acute otitis media requires all three of the following elements for diagnosis: (1) acute onset of symptoms (ear pain, irritability, fever), (2) objective evidence of middle ear effusion documented by impaired tympanic membrane mobility on pneumatic otoscopy, bulging, or air-fluid level, and (3) signs of middle ear inflammation such as moderate-to-severe bulging, new otorrhea not due to otitis externa, or mild bulging with recent-onset pain (<48 hours) or intense erythema 1, 2.

• Perform pneumatic otoscopy as the primary diagnostic tool; bulging of the tympanic membrane is the most important predictor of bacterial AOM, with 96% sensitivity and 89% specificity when middle ear effusion is present 3.
• If pneumatic otoscopy is equivocal, obtain tympanometry to confirm middle ear effusion 1.
• Isolated tympanic membrane redness without bulging or effusion should not be treated with antibiotics 1, 2.

Immediate Pain Management (Mandatory for All Patients)

Analgesics must be initiated immediately in every patient with AOM, regardless of antibiotic decision, because antibiotics provide no symptomatic relief in the first 24 hours 1, 2.

• Administer weight-based acetaminophen or ibuprofen promptly and continue throughout the acute phase (at least 24–48 hours) 1, 2.
• Approximately 30% of children younger than 2 years still have pain or fever after 3–7 days of antibiotic therapy 1.

Severity Classification

Severe AOM is defined by any of the following: moderate-to-severe otalgia, otalgia persisting ≥48 hours, or fever ≥39°C (102.2°F) 1, 2.

Treatment Algorithm by Age and Severity

Infants <6 Months

• All infants younger than 6 months require immediate antibiotic therapy; observation is not an option due to higher complication risk and difficulty monitoring clinical status 1, 2.
• Prescribe high-dose amoxicillin 80–90 mg/kg/day divided twice daily for a mandatory 10-day course 1, 2, 4.

Children 6–23 Months

• Immediate antibiotics are required for: bilateral AOM (regardless of severity), severe AOM (as defined above), or AOM with otorrhea and middle ear effusion 1, 2.
• Observation without immediate antibiotics is appropriate for: unilateral non-severe AOM when reliable follow-up within 48–72 hours can be ensured 1, 2.
• Provide a safety-net prescription to be filled only if symptoms worsen or fail to improve within 48–72 hours 1.

Children 2–5 Years

• Immediate antibiotics are indicated for: severe AOM or when reliable follow-up cannot be guaranteed 1, 2.
• Observation is appropriate for: non-severe AOM (unilateral or bilateral) with dependable 48–72 hour follow-up 1, 2.

Children 6–12 Years and Adults

• Immediate antibiotics are advised for: severe symptoms or when reliable follow-up is unavailable 1.
• Observation may be chosen for: non-severe AOM with reliable 48–72 hour follow-up 1.

First-Line Antibiotic Selection

High-dose amoxicillin (80–90 mg/kg/day divided twice daily, maximum 2 g per dose) is the first-line antibiotic for most patients with AOM 1, 2.

• This dosing achieves middle ear fluid concentrations adequate to overcome penicillin-resistant Streptococcus pneumoniae (approximately 35% of isolates), beta-lactamase-negative Haemophilus influenzae, and Moraxella catarrhalis 1, 2.
• Adult dosing: 1.5–4 g/day divided 1.

When to Use Amoxicillin-Clavulanate First-Line

Switch to amoxicillin-clavulanate (amoxicillin component 90 mg/kg/day + clavulanate 6.4 mg/kg/day in two divided doses) when any of the following are present 1, 2:

• Amoxicillin use within the preceding 30 days 1, 2
• Concurrent purulent conjunctivitis (strongly suggests H. influenzae infection) 1, 2
• Attendance at daycare or high prevalence of beta-lactamase-producing organisms 1, 2
• Recurrent AOM unresponsive to amoxicillin 2

Twice-daily dosing of amoxicillin-clavulanate results in significantly less diarrhea than three-times-daily dosing while maintaining equivalent efficacy 1, 2, 5.

Penicillin-Allergy Alternatives

For non-IgE-mediated (non-severe) penicillin allergy, the preferred oral alternatives are 1, 2:

• Cefdinir 14 mg/kg/day once daily (first choice due to convenient dosing) 1, 2, 6

• Cefuroxime 30 mg/kg/day divided twice daily 1, 2

• Cefpodoxime 10 mg/kg/day divided twice daily 1, 2

• Cross-reactivity between penicillins and second/third-generation cephalosporins is approximately 0.1%, far lower than the historically cited 10%, making these agents generally safe for non-severe penicillin allergy 1, 2.

For IgE-mediated (severe) penicillin allergy:

• Azithromycin may be used, but recognize it is significantly less effective than amoxicillin, with bacterial failure rates of 20–25% due to pneumococcal macrolide resistance exceeding 40% in the United States 1, 7.
• Do not use trimethoprim-sulfamethoxazole or erythromycin-sulfisoxazole due to substantial resistance 1, 2.

Treatment Duration

Treatment duration depends on age and severity 1, 2:

• Children <2 years: 10 days for all episodes, regardless of severity 1, 2, 4
• Children 2–5 years: 7 days for mild-moderate symptoms; 10 days for severe symptoms 1, 2
• Children ≥6 years: 5–7 days for mild-moderate symptoms; 10 days for severe symptoms 1, 2

Management of Treatment Failure

Reassess the patient at 48–72 hours if symptoms worsen or fail to improve; confirm the diagnosis with proper tympanic membrane visualization 1, 2.

Treatment Escalation Algorithm:

1. If initially observed without antibiotics: Start high-dose amoxicillin 1, 2

2. If amoxicillin fails: Switch to amoxicillin-clavulanate (amoxicillin component 90 mg/kg/day) 1, 2

3. If amoxicillin-clavulanate fails: Administer intramuscular ceftriaxone 50 mg/kg once daily (maximum 1–2 g) for 3 consecutive days 1, 2

   • A 3-day ceftriaxone course is superior to a single-dose regimen 1, 2

4. After multiple failures: Consider tympanocentesis with culture and susceptibility testing 1, 2

   • If tympanocentesis is unavailable, use clindamycin with or without coverage for H. influenzae and M. catarrhalis 1, 2
   • For multidrug-resistant S. pneumoniae serotype 19A, levofloxacin or linezolid may be used only after infectious disease and otolaryngology specialist consultation 1, 2

Post-Treatment Follow-Up

Middle ear effusion persists in 60–70% of children at 2 weeks after successful therapy, declining to 40% at 1 month and 10–25% at 3 months 1, 2.

• This post-AOM effusion (otitis media with effusion) requires monitoring but not antibiotics unless it persists >3 months with documented hearing loss 1, 2.
• Routine follow-up visits are not necessary for all children; consider reassessment for infants <6 months, children with severe initial presentations, recurrent AOM, developmental delays, or when parents request it 1, 2.

Recurrent AOM Management

Recurrent AOM is defined as ≥3 episodes in 6 months or ≥4 episodes in 12 months with at least one episode in the preceding 6 months 1, 2.

Prevention Strategies:

• Administer pneumococcal conjugate vaccine (PCV-13) and annual influenza vaccination 1, 2
• Encourage exclusive breastfeeding for at least 6 months 1, 2
• Reduce or eliminate pacifier use after 6 months of age 1, 2
• Avoid supine bottle feeding 1, 2
• Eliminate tobacco smoke exposure 1, 2
• Minimize daycare attendance when feasible 1, 2

Surgical Intervention:

• Tympanostomy tubes are indicated for children meeting recurrent AOM criteria, with failure rates of approximately 21% for tubes alone and 16% for tubes combined with adenoidectomy 1, 2.
• Long-term prophylactic antibiotics are not recommended because modest benefit does not justify the risk of antimicrobial resistance 1, 2.

Critical Pitfalls to Avoid

• Antibiotics do not prevent complications: 33–81% of children who develop acute mastoiditis had received antibiotics previously 1, 2.
• Do not prescribe antibiotics for isolated tympanic membrane redness without bulging or effusion 1, 2.
• Do not use topical antibiotics for AOM; they are reserved for otitis externa or tube otorrhea 1, 2.
• Do not use systemic corticosteroids for AOM; evidence shows no benefit 1, 2.
• Do not treat post-AOM effusion (OME) with antibiotics, decongestants, antihistamines, or nasal steroids; they are ineffective 1, 2.
• Do not use azithromycin as first-line therapy; pneumococcal macrolide resistance exceeds 40% in the United States 1.