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Single dose amoxicillin treatment of acute otitis media
Insights
A single dose of amoxicillin was less effective than a 10-day course for treating acute otitis media (AOM) in children. The single-dose amoxicillin group showed significantly more treatment failures, leading to study termination.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Acute otitis media (AOM) is a common childhood infection.
- Amoxicillin is a standard treatment for AOM.
- Optimizing antibiotic treatment duration for AOM is crucial to balance efficacy and minimize resistance.
Purpose of the Study:
- To compare the efficacy of a single dose of amoxicillin versus a 10-day course in treating pediatric AOM.
- To evaluate treatment outcomes and identify potential failures in different amoxicillin dosing regimens.
Main Methods:
- A double-blind study enrolled children diagnosed with AOM.
- Participants were randomized to receive either a single dose of amoxicillin or a 10-day course.
- Tympanocentesis was performed, and patients were monitored on days 3 and 10 post-treatment.
Main Results:
- Seventeen patients were enrolled; 7 received single-dose therapy and 10 received 10-day therapy.
- Three treatment failures occurred in the single-dose group (days 5, 6, 11) (p = 0.05).
- No failures were observed in the 10-day treatment group.
Conclusions:
- A single dose of amoxicillin is not effective for treating acute otitis media in children.
- A 10-day course of amoxicillin demonstrated superior efficacy in this pediatric AOM study.
- The study was terminated early due to a high failure rate in the single-dose treatment arm.
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.