From the Guidelines
For a patient with otitis media who remains symptomatic after 7 days of Augmentin treatment, the next step should be referral to an otolaryngologist (ENT specialist) for evaluation and possible tympanocentesis (ear fluid drainage). The patient's persistent symptoms despite 7 days of Augmentin treatment suggest that the initial antibiotic therapy may not be effective, and further evaluation is necessary to determine the cause of the ongoing infection 1.
Possible Causes of Persistent Symptoms
- Antibiotic resistance
- Non-bacterial cause
- Complications such as mastoiditis
- Underlying conditions that could impair treatment response, such as immunodeficiency or anatomical abnormalities The ENT specialist may perform a culture and sensitivity test of the middle ear fluid to identify the specific pathogen and its antibiotic susceptibility 1.
Alternative Antibiotic Options
- Ceftriaxone (50 mg/kg IM or IV daily for 3 days)
- Clindamycin (30-40 mg/kg/day divided into 3 doses for 10 days) While awaiting the appointment, the patient should continue pain management with acetaminophen or ibuprofen and apply warm compresses to the affected ear for comfort 1.
Importance of Prompt Specialist Attention
Persistent otitis media requires prompt specialist attention to prevent complications like hearing loss or spread of infection 1. It is essential to note that the American Academy of Pediatrics recommends considering a change in antibiotic therapy if the patient is not improved by 48 to 72 hours 1. In this case, since the patient has already exceeded the 7-day treatment period, referral to an ENT specialist is the most appropriate next step.
From the FDA Drug Label
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 (amoxicillin/clavulanate potassium). The patient has already been on Augmentin (Amoxicillin-Clavulanate) for 7 days and remains symptomatic, the next step is unclear from the provided information.
- The provided drug labels do not directly address the next steps for a patient who remains symptomatic after 7 days of treatment with Augmentin.
- No conclusion can be drawn from the provided information regarding the next step for this patient 2, 3.
From the Research
Next Steps for Treatment
If a patient with Otitis media remains symptomatic after 7 days of treatment with Augmentin (Amoxicillin-Clavulanate), the following options can be considered:
- Switching to a different antibiotic, such as a beta-lactamase-stable agent, if no response occurs within 48 to 72 hours 4
- Using high-dose amoxicillin, with or without clavulanate, or clindamycin if penicillin-resistant pneumococcus is suspected 4
- Considering alternative treatments, such as intramuscular ceftriaxone, which has been shown to be as efficient as oral amoxicillin-clavulanate for treatment of acute otitis media in children 5
Factors to Consider
When choosing an antibiotic, the following factors should be considered:
- Proven efficacy
- Cost
- Side effect profile
- Compliance issues
- Spectrum of coverage
- Age of the child 6
Resistance and Efficacy
Studies have shown that amoxicillin-clavulanate has high success rates for both S. pneumoniae and H. influenzae, with low resistance rates compared to other countries 7
- The clinical efficacy of amoxicillin-clavulanate was found to be equal compared to azithromycin in children with acute otitis media 7
Recurrence and Prophylaxis
Children with recurrent infections may benefit from antibiotic prophylaxis 6
- Referral for insertion of tympanostomy tubes is most appropriate for patients with documented language delay and/or significant medical complications 6