What is the next step in managing bilateral otitis media (ear infection) that has not responded to a 5-day course of azithromycin (Zithromax)?

From the Guidelines

For a bilateral ear infection not responding to a 5-day course of azithromycin, I recommend switching to amoxicillin-clavulanate (Augmentin) at a dose of 875/125 mg twice daily for 10 days. This recommendation is based on the most recent and highest quality study available, which suggests that the choice of antibacterial agent after initial failure of first-line antibacterial therapy should be based on the likely pathogen(s) present or the physician's clinical experience 1. The lack of improvement with azithromycin suggests either resistant bacteria or possibly a viral infection. Azithromycin has limited coverage against common ear pathogens like Haemophilus influenzae and Moraxella catarrhalis.

Key Considerations

• If the patient has a penicillin allergy, consider cefdinir 300 mg twice daily for 10 days or clindamycin 300 mg three times daily for 10 days.
• Pain relief can be managed with over-the-counter analgesics like acetaminophen or ibuprofen.
• Warm compresses applied to the ears may also help alleviate discomfort.
• The goals of antimicrobial therapy for AOM are the rapid resolution of signs and symptoms of disease; sterilization of the middle ear effusion; prevention of suppurative sequelae; reduction of the occurrence of relapse and recurrences; and decrease in time spent with middle ear effusion 1.

Next Steps

• If symptoms persist after completing the second antibiotic course, further evaluation by an ENT specialist is warranted to rule out complications or other conditions.
• Patients should complete the full course of antibiotics even if symptoms improve before completion to prevent recurrence and antibiotic resistance.
• A second aspiration of middle-ear fluid should be considered for any patient for whom the outcome at 72 hours is clinical failure 1.

From the FDA Drug Label

CLINICAL STUDIES SECTION Pediatric Patients From the perspective of evaluating pediatric clinical trials, Days 11 to 14 were considered on-therapy evaluations because of the extended half-life of azithromycin. For the 553 patients who were evaluated for clinical efficacy, the clinical success rate (i. e., cure plus improvement) at the Day 11 visit was 88% for azithromycin and 88% for the control agent. For the 521 patients who were evaluated at the Day 30 visit, the clinical success rate was 73% for azithromycin and 71% for the control agent

The next step in managing bilateral otitis media that has not responded to a 5-day course of azithromycin is not explicitly stated in the provided drug label.

• The label provides information on the clinical success rate of azithromycin in treating acute otitis media, but it does not provide guidance on what to do if the infection does not respond to the initial treatment.
• Therefore, no conclusion can be drawn from the provided information. 2

From the Research

Next Steps in Managing Bilateral Otitis Media

• If a 5-day course of azithromycin has not been effective in treating bilateral otitis media, the next step could be to consider alternative antibiotic treatments, such as amoxicillin/clavulanic acid, as suggested by studies 3 that compared the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media.
• Amoxicillin/clavulanic acid was found to be more effective in eradicating bacterial pathogens, including Haemophilus influenzae and Streptococcus pneumoniae, from middle ear fluid than azithromycin 3.
• The choice of alternative antibiotic treatment should be based on the specific needs of the patient, including the severity of the infection, the presence of any underlying medical conditions, and the patient's previous response to antibiotic treatment.
• Other studies have compared the efficacy of azithromycin with other antibiotics, such as cefaclor 4 and amoxicillin-clavulanic acid 5, 6, in the treatment of various infections, including acute otitis media and community-acquired pneumonia.

Considerations for Alternative Treatments

• The efficacy and safety of alternative antibiotic treatments, such as amoxicillin/clavulanic acid, should be considered when deciding on the next step in managing bilateral otitis media that has not responded to azithromycin.
• Studies have shown that amoxicillin/clavulanic acid is effective in treating acute otitis media and has a similar safety profile to azithromycin 3, 7.
• The decision to switch to an alternative antibiotic treatment should be based on the individual patient's needs and the specific circumstances of the case.