What is the empiric treatment for acute otitis media (AOM)?

Empiric Treatment of Acute Otitis Media

First-Line Antibiotic Therapy

High-dose amoxicillin (80-90 mg/kg/day divided into two doses) is the first-line empiric treatment for acute otitis media in children, while amoxicillin-clavulanate is preferred for adults. 1, 2, 3

Pediatric Dosing

• Amoxicillin 80-90 mg/kg/day divided twice daily for most children 1, 2, 3
• This high-dose regimen achieves 92% eradication of S. pneumoniae (including penicillin-nonsusceptible strains) and 84% eradication of beta-lactamase-negative H. influenzae 4
• Standard 40 mg/kg/day dosing is inadequate for resistant pathogens, particularly during viral coinfection 5

Adult Dosing

• Amoxicillin-clavulanate is preferred as first-line for adults (provides coverage against beta-lactamase-producing organisms and resistant pneumococci) 4
• Adult amoxicillin dosing: 1.5-4 g/day when used alone 2

Treatment Duration

Duration varies by age and severity:

• 10 days for children <2 years and those with severe symptoms 1, 2, 3
• 7 days for children 2-5 years with mild-to-moderate AOM 1, 3
• 5-7 days for children ≥6 years with mild-to-moderate symptoms 3
• 5-7 days typically recommended for adults 4

The shorter 7-day course in children 2-5 years is equally effective as 10 days based on systematic review evidence showing no difference in clinical cure (RR 1.02,95% CI 0.95-1.09) 1

Second-Line Therapy

Switch to amoxicillin-clavulanate (90 mg/kg/day based on amoxicillin component) if:

• Patient received amoxicillin in the previous 30 days 2, 3, 4
• Concurrent purulent conjunctivitis is present 3, 4
• Symptoms worsen or fail to improve within 48-72 hours 1, 2, 3
• High likelihood of beta-lactamase-producing organisms (H. influenzae, M. catarrhalis) 6, 7

Alternative Second-Line Options

• Ceftriaxone 50 mg/kg IM/IV daily for 1-3 days (3-day regimen superior to single dose) 1, 3, 8
• For penicillin allergy (non-type I): cefdinir (14 mg/kg/day), cefuroxime (30 mg/kg/day), or cefpodoxime (10 mg/kg/day) 2, 3, 4

The WHO Expert Committee specifically excluded cefuroxime and ceftriaxone from routine first-line recommendations to reduce emphasis on empiric coverage for penicillin-resistant S. pneumoniae and favor oral over parenteral options 1

Observation Without Immediate Antibiotics

Watchful waiting (48-72 hours) is appropriate for:

• Children ≥2 years with non-severe, unilateral AOM and reliable follow-up 2, 4
• Children ≥2 years with uncertain diagnosis 2
• Otherwise healthy children with mild symptoms 2

Immediate antibiotics are mandatory for:

• All children <6 months 2, 4
• Children 6-23 months with bilateral AOM or severe symptoms 2, 4
• Any child with otorrhea 2
• Adults with AOM 1, 4

Systematic review evidence shows antibiotics reduce residual pain at 2-3 days (RR 0.70,95% CI 0.57-0.86) and tympanic membrane perforations (RR 0.37,95% CI 0.18-0.76), but increase adverse events (RR 1.38,95% CI 1.19-1.59) 1. The number needed to treat is approximately 3-4 in children <2 years with bilateral AOM 1

Pain Management

Initiate analgesics immediately in all patients, regardless of antibiotic decision:

• Acetaminophen or ibuprofen should be started within the first 24 hours 2, 3, 4
• Continue as long as needed, as pain often persists even after 3-7 days of antibiotics (30% of children <2 years) 3
• Antibiotics provide no symptomatic relief in the first 24 hours 3

Critical Pitfalls to Avoid

Do not confuse otitis media with effusion (OME) with acute AOM:

• 60-70% of children have middle ear effusion at 2 weeks post-treatment, 40% at 1 month, and 10-25% at 3 months 1, 2, 3
• Persistent effusion without acute symptoms is OME and requires monitoring only—not antibiotics 1, 2, 3

Do not use these agents as first-line:

• Azithromycin (inferior efficacy: 83-89% clinical success vs. 88% with amoxicillin-clavulanate) 9
• Fluoroquinolones (not approved for children; reserve for multidrug-resistant cases after tympanocentesis) 1
• Corticosteroids (no evidence of benefit in AOM) 2

Do not stop antibiotics prematurely:

• Treatment failure occurs in 21% with inadequate treatment versus 5% with complete course 2
• Complete the full prescribed duration even if symptoms resolve 2

Common Pathogens

The three primary bacterial pathogens are identical in children and adults:

• Streptococcus pneumoniae (including penicillin-resistant strains) 1, 3, 4
• Nontypeable Haemophilus influenzae (>30% produce beta-lactamase) 6, 7
• Moraxella catarrhalis (virtually all strains beta-lactamase-positive) 6, 7