Related Experiment Videos
Co-amoxiclav in recurrent acute otitis media: placebo controlled study
C L Appelman1, J Q Claessen, F W Touw-Otten
1Department of General Practice, University of Utrecht, The Netherlands.
Insights
Co-amoxiclav did not show significant benefit over placebo for treating recurrent acute otitis media in children over two years old. Children under two years old had a higher risk of irregular disease course, regardless of treatment.
Area of Science:
- Pediatrics
- Infectious Diseases
- Clinical Pharmacology
Background:
- Recurrent acute otitis media (RAOM) is common in children.
- Identifying effective treatments for RAOM is crucial for managing pediatric ear infections.
Purpose of the Study:
- To evaluate the efficacy of co-amoxiclav compared to placebo in children aged 6 months to 12 years with RAOM.
- To identify prognostic factors for the clinical course of RAOM in this pediatric population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted in general practice in the Netherlands.
- 121 children with RAOM received either oral co-amoxiclav or placebo for seven days.
- The primary outcome measure was an irregular clinical course, defined as the presence of otalgia or fever (≥38°C) after three days.
Main Results:
- No significant difference in irregular clinical course was observed between the co-amoxiclav and placebo groups (16% vs. 19%).
- Age was a significant prognostic factor, with children under 2 years old having a higher risk of irregular disease course (28% co-amoxiclav vs. 58% placebo).
- In children aged 2 years and older, irregular courses were observed in 13% of the co-amoxiclav group and 7% of the placebo group.
Conclusions:
- Co-amoxiclav offers no significant advantage over placebo for treating RAOM in children over two years old.
- Children with RAOM face a higher risk of an irregular clinical course compared to those with a first episode of acute otitis media.
Objective:
To determine the efficacy of coamoxiclav in children aged 6 months to 12 years with recurrent acute otitis media.
Design:
A randomised double blind placebo controlled clinical trial.
Setting:
General practice in the Netherlands.
Patients:
121 children with recurrent acute otitis media, defined by onset of otalgia and otoscopic signs of middle ear infection within four to 52 weeks after the previous attack. Confirmation of diagnosis and randomisation was done by otolaryngologists.
Intervention:
Oral co-amoxiclav or placebo in weight related doses for seven days.
Main Outcome Measure:
An irregular clinical course defined as the presence of otalgia or a body temperature greater than or equal to 38 degrees C, or both, after three days.
Results:
Eleven (16%; 95% confidence interval 9% to 28%) children had an irregular course in the co-amoxiclav group and 10 (19%; 9% to 31%) in the placebo group (difference not significant). Age, dichotomised at 2 years, was the only significant prognostic factor for irregular course of the disease (odds ratio 5.9; 1.8 to 19.1). Among children aged below 2 years, 28% (4/14) in the co-amoxiclav group and 58% (7/12) in the placebo group had irregular courses. For children 2 years and older these percentages were 13% (7/52) and 7% (3/41).
Conclusion:
Children with recurrent acute otitis media are at greater risk of an irregular clinical course of the disease than children with a first episode of acute otitis media. Co-amoxiclav has no significant benefit over placebo in treating children over 2 years with acute otitis media.