What is the treatment for acute Otitis Media (inflammation of the middle ear)?

From the Guidelines

The treatment for acute otitis media should involve amoxicillin as the first-line antibiotic, prescribed at 80-90 mg/kg/day, as recommended by the most recent and highest quality study 1. The choice of amoxicillin is based on its effectiveness against the most common bacterial pathogens, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.

• The dosage of 80-90 mg/kg/day is supported by studies, such as 1, which suggests that this dosage is effective against susceptible and intermediate resistant pneumococci.
• For penicillin-allergic patients, alternatives such as amoxicillin-clavulanic acid may be considered, as recommended by 1.
• Pain management with acetaminophen or ibuprofen is also essential, as it can help alleviate symptoms and improve quality of life.
• Supportive measures, including adequate hydration, rest, and avoiding smoke exposure, should also be implemented to help manage the condition.
• It is important to note that antibiotics may not always be necessary, and a strategy of watchful waiting could reduce unnecessary antibiotic use, as suggested by 1.
• However, for severe cases or recurrent infections, antibiotics such as amoxicillin or amoxicillin-clavulanic acid may be necessary to prevent complications and improve outcomes.

From the FDA Drug Label

Acute Otitis Media Safety and efficacy using azithromycin 30 mg/kg given over 5 days Protocol 1 In a double-blind, controlled clinical study of acute otitis media performed in the United States, azithromycin (10 mg/kg on Day 1 followed by 5 mg/kg on Days 2 to 5) was compared to amoxicillin/clavulanate potassium (4:1). 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 Protocol 2 In a non-comparative clinical and microbiologic trial performed in the United States, where significant rates of beta-lactamase producing organisms (35%) were found, 131 patients were evaluable for clinical efficacy. The combined clinical success rate (i.e., cure and improvement) at the Day 11 visit was 84% for azithromycin. For the 122 patients who were evaluated at the Day 30 visit, the clinical success rate was 70% for azithromycin. Microbiologic determinations were made at the pre-treatment visit. Microbiology was not reassessed at later visits. The following presumptive bacterial/clinical cure outcomes (i.e., clinical success) were obtained from the evaluable group: Presumed Bacteriologic Eradication Day 11 Day 30 Azithromycin Azithromycin S. pneumoniae 61/74 (82%) 40/56 (71%) H. influenzae 43/54 (80%) 30/47 (64%) M. catarrhalis 28/35 (80%) 19/26 (73%) S pyogenes 11/11 (100%) 7/7 Overall 177/217 (82%) 97/137 (73%)

Treatment for Acute Otitis Media:

• Azithromycin is effective in the treatment of acute otitis media, with a clinical success rate of 88% at Day 11 and 73% at Day 30 in one study 2.
• The microbiologic cure rates for azithromycin were 82% for S. pneumoniae, 80% for H. influenzae, and 80% for M. catarrhalis at Day 11 2.
• Amoxicillin-clavulanate is also used to treat acute otitis media, but the provided text does not directly compare its efficacy to azithromycin in this context 3.
• Ceftriaxone is indicated for the treatment of acute bacterial otitis media caused by susceptible organisms, including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis 4.

From the Research

Treatment Options for Acute Otitis Media

• High-dose amoxicillin (80 to 90 mg/kg/d divided twice daily) is the recommended treatment for acute otitis media, despite increasing antimicrobial resistance 5.
• For persistent or recurrent acute otitis media, guidelines recommend high-dose amoxicillin/clavulanate (90/6.4 mg/kg/d), cefdinir, cefprozil, cefpodoxime, cefuroxime, or ceftriaxone 5.
• Increasing the dose of amoxicillin does not cover infection with beta-lactamase-producing pathogens; adding the beta-lactamase inhibitor clavulanate to amoxicillin, or choosing a cephalosporin with good activity against S pneumoniae and good beta-lactamase stability, is recommended 5.

Pain Relief in Acute Otitis Media

• Paracetamol (acetaminophen) and non-steroidal anti-inflammatory drugs (NSAIDs) are regarded as the cornerstone of acute otitis media management in children, as antibiotics provide only marginal benefits 6, 7.
• Low-quality evidence indicates that both paracetamol and ibuprofen as monotherapies are more effective than placebo in relieving short-term ear pain in children with acute otitis media 6, 7.
• There is insufficient evidence of a difference between ibuprofen and paracetamol in relieving short-term ear pain in children with acute otitis media 6, 7.

Comparison of Antibiotics

• Twice-daily trimethoprim-sulfamethoxazole has been shown to be more effective clinically and produces fewer side effects than twice-daily amoxicillin-clavulanate in the treatment of acute otitis media 8.
• Amoxicillin-clavulanate potassium is effective in vitro against all bacterial pathogens causing acute otitis media, but its clinical efficacy is lower than that of trimethoprim-sulfamethoxazole 8.