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High-dose versus standard-dose amoxicillin for acute otitis media
Gina Daubney Garrison1, Paul C Sorum, Wayne Hioe
1Department of Pharmacy Practice, Albany College of Pharmacy, Albany, NY 12208, USA. garrisog@acp.edu
The Annals of Pharmacotherapy
|January 27, 2004
Summary
High-dose amoxicillin (HD) showed no significant benefit over standard-dose amoxicillin (SD) for treating acute otitis media (AOM) in low-risk children. Both doses demonstrated similar efficacy and tolerability, with no increased adverse effects from HD amoxicillin.
Area of Science:
- Pediatric infectious diseases
- Pharmacology and therapeutics
- Bacterial resistance mechanisms
Background:
- Rising antibiotic resistance necessitates evaluating optimal treatment strategies for pediatric acute otitis media (AOM).
- High-dose (HD) amoxicillin (80-90 mg/kg/d) is recommended over standard-dose (SD) amoxicillin (40-45 mg/kg/d) for AOM.
- This study focuses on children at low risk for antibiotic-resistant bacteria.
Purpose of the Study:
- To compare the efficacy and tolerability of HD versus SD amoxicillin in children with AOM.
- To assess treatment success, duration of illness, healthcare utilization, subsequent AOM episodes, and adverse effects.
Main Methods:
- A double-blind, randomized clinical trial over 3 years.
- Inclusion criteria: age >3 months, weight ≤18 kg, diagnosed AOM, eligible for amoxicillin.
- Primary endpoint: treatment success at 3-4 days based on continued amoxicillin therapy.
Main Results:
- No significant difference in antibiotic failure rates between SD and HD amoxicillin (p = 0.78).
- Similar mean duration of illness (3 ± 2 days) for both doses.
- No differences in subsequent AOM episodes, healthcare visits, or adverse effects between groups.
Conclusions:
- HD amoxicillin offers no discernible benefit over SD amoxicillin for AOM in children at low risk for resistant infections.
- Both amoxicillin doses were equally effective and well-tolerated in this low-risk pediatric population.