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NOT YET RECRUITING
NCT07878910
PHASE4

Amoxicillin-clavulanate Versus Amoxicillin Versus Placebo in Acute Otitis Media in Children

Sponsor: Kuopio University Hospital

View on ClinicalTrials.gov

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

DRUG

Amoxicillin

Amoxicillin administered twice daily for seven days

DRUG

Amoxicillin + Clavulanate

Amoxicillin-clavunate administered twice daily for seven days

DRUG

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