Q&A

High-dose azithromycin or amoxicillin-clavulanate for recurrent otitis media?

J Fam Pract. 2004 March;53(3):172-188
By
Adrienne Z. Ables, PharmD
Petra K. Warren, MD
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  • BACKGROUND: High-dose amoxicillin-clavulanate is recommended for children with acute otitis media (AOM) who have not improved on previous treatment or have had recent antimicrobial exposure.1 Azithromycin is an alternative only for patients with documented allergy to beta-lactam antibiotics.
  • POPULATION STUDIED: The authors studied 304 patients aged between 6 months and 6 years with recurrent or persistent AOM. AOM was diagnosed by the presence of at least 2 of the following: decreased or absent mobility of the tympanic membrane, yellow or white discoloration, opacification, or acute perforation with purulence. In addition, 1 of the following had to be present to make the diagnosis: ear pain within 24 hours, hyperemia of the tympanic membrane, or bulging of the tympanic membrane.
  • STUDY DESIGN AND VALIDITY: Patients were enrolled into the trial in 13 US and 5 Latin American centers. Patients were randomly assigned to receive high-dose amoxicillin-clavulanate at 90/6.4 mg/kg/d for 10 days plus azithromycin placebo or high-dose azithromycin, 20 mg/kg/d, for 3 days plus amoxicillin-clavulanate placebo. Clinical, otoscopic, and safety assessments were made at baseline, after 2 weeks, and at the end of the study (days 28–32). Additionally, tympanocentesis was performed before the study drug was administered and pathogens from middle-ear fluid samples were isolated and identified.
  • OUTCOMES MEASURED: The primary endpoint of the study was clinical response (cure, improvement, or worsening) at day 28 to 32. The secondary endpoint was clinical response at days 12 to 16. Adverse effects were also recorded.
  • RESULTS: After 1 month, the clinical response rate (cure or improvement) of azithromycin was slightly greater than amoxicillin-clavulanate—72% vs 61%, respectively (P=.047, number needed to treat=9). At days 12 to 16, clinical success rates were similar between the 2 groups (about 85%).
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PRACTICE RECOMMENDATIONS

Use high-dose azithromycin for 3 days if antibiotics are needed, instead of a 10-day course of high-dose amoxicillin-clavulanate for the treatment of recurrent or persistent acute otitis media. For every 10 children using azithromycin instead of amoxicillin-clavulanate, there is 1 additional clinical cure at 1 month and 1 less episode of diarrhea. However, no difference in clinical success is seen at 2 weeks.

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