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Clinical Trial
. 1987 Jan;97(1):16-8.
doi: 10.1288/00005537-198701000-00006.

Single dose amoxicillin treatment of acute otitis media

Clinical Trial

Single dose amoxicillin treatment of acute otitis media

M S Puczynski et al. Laryngoscope. 1987 Jan.

Abstract

A double blind study comparing a single dose of amoxicillin versus a 10-day course of amoxicillin in the treatment of acute otitis media (AOM) was undertaken. All children diagnosed with AOM in a pediatric clinic were requested to participate. After tympanocentesis was performed, patients were randomly assigned to receive either amoxicillin (100 mg/kg) followed by placebo every 8 hours for 10 days or placebo followed by amoxicillin (40 mg/kg/D) for 10 days. Patients returned to clinic on days 3 and 10 post-treatment. Seventeen patients were enrolled: 7 received single dose therapy and 10 received 10 days of therapy. There were no failures in the control group and 3 failures in the single dose group (day 5, day 6, and 11) (p = 0.05). Middle ear isolates included: S. pneumoniae 7, H. influenzae 4, B. catarrhalis 1, and no pathogen in 5. Due to the significant number of failures in the treatment group, the study was prematurely terminated.

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