Five vs. ten days of antibiotic therapy for acute otitis media in young children
1Department of Microbiology and Pediatrics, Intercommunal Hospital of Créteil, France. robert.cohen@wanadoo.fr
Insights
A 10-day antibiotic course for acute otitis media showed higher initial success than a 5-day course in young children. However, long-term outcomes were similar, suggesting shorter antibiotic durations may be viable.
Area of Science:
- Pediatrics
- Infectious Diseases
- Pharmacology
Background:
- Shortened antibiotic therapy for acute otitis media is increasingly advocated.
- Concerns remain regarding efficacy in children under two years old.
- Some guidelines restrict shorter courses to children over two years.
Purpose of the Study:
- To compare the efficacy of a 5-day versus a 10-day regimen of cefpodoxime-proxetil for acute otitis media in children.
- To evaluate clinical success rates at the conclusion of therapy and during follow-up.
Main Methods:
- A prospective, comparative, double-blind, randomized, multicenter trial was conducted.
- 450 children (mean age 14.3 months) received either a 5-day or a 10-day course of cefpodoxime-proxetil.
- Clinical success was assessed at the end of treatment and 4-6 weeks post-enrollment.
Main Results:
- The 10-day regimen achieved a higher clinical success rate (92.4%) compared to the 5-day regimen (84.1%) at the end of therapy (P=0.009).
- This difference was more pronounced in children cared for outside the home.
- No significant difference in clinical success was observed between the groups at 4-6 weeks post-enrollment (85.4% vs. 83.7%, P=0.68).
Conclusions:
- A 10-day antibiotic course demonstrated superior short-term efficacy for acute otitis media in young children.
- Long-term outcomes were comparable between 5-day and 10-day regimens.
- These findings suggest that shorter antibiotic courses may be effective for acute otitis media in children, particularly when considering longer-term resolution.
Background:
Many publications in recent years have argued in favor of shortened therapy for acute otitis media. However, doubt persists regarding children younger than 2 years, and some authors therefore restrict short course therapy to children older than 2 years.
Methods:
In a prospective, comparative, double blind, randomized, multicenter trial we compared cefpodoxime-proxetil, 8 mg/kg/day in two divided doses for 10 days, with an identical 5-day regimen followed by a 5-day placebo period.
Results:
Between October, 1996, and April, 1997, 450 children (mean age, 14.3 months) were enrolled, 227 in the 5-day group and 223 in the 10-day group. In the per protocol analysis clinical success was obtained on Days 12 to 14 after the beginning of treatment (main analysis) in 175 (84.1%) of the 208 children receiving the 5-day regimen and 194 (92.4%) of the 210 children receiving the 10-day regimen (P = 0.009). The superiority of the standard regimen was more marked among children cared for outside their homes (92.5% vs. 81.5%). Clinical success persisted on Days 28 to 42 among 134 (85.4%) of the 157 assessable patients in the 5-day group and 144 (83.7%) of the 172 assessable patients in the 10-day group (P = 0.68).
Conclusions:
The 10-day regimen resulted in a higher success rate at the conclusion of therapy, but there were no differences between the two study groups 4 to 6 weeks after enrollment in the study protocol.
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