Phase 4Not yet recruiting
Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children (SAVOtitis)
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
- Sponsor
- Kuopio University Hospital (Academic or other)
- Enrollment
- 219 planned
- Conditions
- Acute Otitis Media; AOM - Acute Otitis Media
- Interventions
- Amoxicillin; Amoxicillin + Clavulanate; Placebo
- Ages
- children
- Registry
- NCT07878910, CTIS2025-524259-30-00
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Symptoms of the child
History
Study completion expected
Primary completion expected
Started
Registered