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Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children
Sponsor: Kuopio University Hospital
Summary
The goal of this trial is to compare amoxicillin to amoxicillin-clavulanate and to placebo in the treatment of acute middle ear infections in small children. It will also learn about the possible side effects of antibiotics as compared to placebo. The main questions it aims to answer are: * Does treatment with antibiotics, either amoxicillin or amoxicillin-clavulanate, shorten the duration of symptoms in children with acute ear infection and what is the balance between pros and cons of antibiotics? Participants will: Take one of the two antibiotics or a placebo every day for 7 days.
Official title: Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children Aged 6-35 Months - A Parallel-grouped Triple-blinded Randomized Controlled Superiority Trial
Key Details
Gender
All
Age Range
6 Months - 35 Months
Study Type
INTERVENTIONAL
Enrollment
219
Start Date
2026-11-01
Completion Date
2030-12-31
Last Updated
2026-10-16
Healthy Volunteers
No
Interventions
Amoxicillin
Amoxicillin administered twice daily for seven days
Amoxicillin + Clavulanate
Amoxicillin-clavunate administered twice daily for seven days
Placebo
Placebo administered twice daily for seven days
Locations (3)
Kuopio University Hospital
Kuopio, Northern Savonia, Finland
Mikkeli emergency policlinics
Mikkeli, Finland
Turku University Hospital
Turku, Finland