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A placebo-controlled trial of antimicrobial treatment for acute otitis media
Paula A Tähtinen1, Miia K Laine, Pentti Huovinen
1Department of Pediatrics, Turku University Hospital, Turku, Finland.
Insights
Antimicrobial treatment with amoxicillin-clavulanate significantly reduced treatment failure in children with acute otitis media compared to placebo. However, this antibiotic also increased the risk of adverse events like diarrhea.
Area of Science:
- Pediatric infectious diseases
- Clinical pharmacology
- Evidence-based medicine
Background:
- The effectiveness of antibiotics for acute otitis media in children is debated.
- This study addresses the controversy by evaluating amoxicillin-clavulanate efficacy.
Purpose of the Study:
- To determine the efficacy of amoxicillin-clavulanate versus placebo in treating acute otitis media in young children.
- To assess treatment failure rates and adverse events.
Main Methods:
- A randomized, double-blind trial involving children aged 6 to 35 months with acute otitis media.
- Participants received either amoxicillin-clavulanate or a placebo for 7 days.
- Treatment failure was defined by clinical condition and otoscopic signs.
Main Results:
- Amoxicillin-clavulanate significantly reduced treatment failure (18.6% vs. 44.9%, P<0.001) and the need for rescue treatment (8.1% vs. 33.5%, P<0.001).
- The antibiotic group experienced more adverse events, notably higher rates of diarrhea (47.8% vs. 26.6%, P<0.001) and eczema (8.7% vs. 3.2%, P=0.04).
Conclusions:
- Amoxicillin-clavulanate offers significant benefits for children with acute otitis media compared to placebo.
- Further research is needed to identify patient subgroups who benefit most, minimizing unnecessary antibiotic use and resistance development.
Background:
The efficacy of antimicrobial treatment in children with acute otitis media remains controversial.
Methods:
In this randomized, double-blind trial, children 6 to 35 months of age with acute otitis media, diagnosed with the use of strict criteria, received amoxicillin-clavulanate (161 children) or placebo (158 children) for 7 days. The primary outcome was the time to treatment failure from the first dose until the end-of-treatment visit on day 8. The definition of treatment failure was based on the overall condition of the child (including adverse events) and otoscopic signs of acute otitis media.
Results:
Treatment failure occurred in 18.6% of the children who received amoxicillin-clavulanate, as compared with 44.9% of the children who received placebo (P<0.001). The difference between the groups was already apparent at the first scheduled visit (day 3), at which time 13.7% of the children who received amoxicillin-clavulanate, as compared with 25.3% of those who received placebo, had treatment failure. Overall, amoxicillin-clavulanate reduced the progression to treatment failure by 62% (hazard ratio, 0.38; 95% confidence interval [CI], 0.25 to 0.59; P<0.001) and the need for rescue treatment by 81% (6.8% vs. 33.5%; hazard ratio, 0.19; 95% CI, 0.10 to 0.36; P<0.001). Analgesic or antipyretic agents were given to 84.2% and 85.9% of the children in the amoxicillin-clavulanate and placebo groups, respectively. Adverse events were significantly more common in the amoxicillin-clavulanate group than in the placebo group. A total of 47.8% of the children in the amoxicillin-clavulanate group had diarrhea, as compared with 26.6% in the placebo group (P<0.001); 8.7% and 3.2% of the children in the respective groups had eczema (P=0.04).
Conclusions:
Children with acute otitis media benefit from antimicrobial treatment as compared with placebo, although they have more side effects. Future studies should identify patients who may derive the greatest benefit, in order to minimize unnecessary antimicrobial treatment and the development of bacterial resistance. (Funded by the Foundation for Paediatric Research and others; ClinicalTrials.gov number, NCT00299455.).
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