Switch to Amoxicillin-Clavulanate (Augmentin)
For an infant with acute otitis media who has failed 72 hours of azithromycin therapy, the next step is to switch to high-dose amoxicillin-clavulanate (augmentin). 1
Rationale for Antibiotic Switch
Azithromycin is not first-line therapy for acute otitis media and has substantial limitations in coverage against the primary pathogens causing AOM, particularly Streptococcus pneumoniae and Haemophilus influenzae. 1
The American Academy of Pediatrics guidelines explicitly state that when patients fail to improve after 48-72 hours of initial antibacterial treatment, the clinician should change the antibacterial agent if AOM is confirmed. 1
High-dose amoxicillin-clavulanate (90 mg/kg/day of amoxicillin component) is the recommended second-line agent when initial therapy fails, providing enhanced coverage against beta-lactamase producing organisms and penicillin-resistant S. pneumoniae. 1
Why Not Reassurance?
Clinical improvement should be noted within 48-72 hours of appropriate antibiotic therapy. 1
At 72 hours without improvement, the causative bacteria are likely resistant to azithromycin, or another disease process may be present. 1
Reassurance alone is inappropriate when a child has documented AOM with treatment failure, as this risks progression to complications including mastoiditis, meningitis, or chronic suppurative otitis media. 1
Why Not ENT Referral at This Stage?
ENT referral is premature at this point, as the standard algorithm requires attempting appropriate second-line antibiotic therapy first. 1
Tympanocentesis and ENT consultation should be considered only after a series of antibiotic drugs have failed to improve the clinical condition, not after a single inadequate first-line agent. 1
The infant has not yet received appropriate first-line therapy (amoxicillin or amoxicillin-clavulanate), so switching to proper coverage is the logical next step. 1
Specific Treatment Recommendation
Prescribe amoxicillin-clavulanate at 90 mg/kg/day (of the amoxicillin component) divided into two doses for this infant. 1
Reassess the patient in 48-72 hours after starting the new antibiotic to confirm clinical improvement (decreased fever, improved irritability, normalized sleeping and drinking patterns). 1
If the patient fails to improve on amoxicillin-clavulanate after 48-72 hours, then consider intramuscular ceftriaxone (50 mg/kg/day for 3 days) or ENT referral for possible tympanocentesis. 1
Critical Pitfall to Avoid
Azithromycin should not have been used as initial therapy for uncomplicated AOM in an infant, as macrolides have bacteriologic failure rates of 20-25% against the primary AOM pathogens and substantial pneumococcal resistance exists. 1, 2
The FDA label data shows azithromycin clinical success rates of only 82-88% at day 11 for AOM, with even lower rates (69-74%) at day 30, compared to amoxicillin-clavulanate. 2