About this trial
This study aims to compare the effectiveness of two treatments for children with acute otitis media (middle ear infection). The two treatments being compared are amoxicillin alone and a combination of amoxicillin plus clavulanic acid. The study will help determine which treatment works better in helping children recover faster and reduce the risk of treatment failure or recurrence. By providing clearer evidence, the research aims to guide better treatment choices for children suffering from this common infection.
Eligibility criteria
Qualifiers
Children aged 1 to 5 years
Diagnosed with acute otitis media (as per operational definition)
Both male and female participants
Parental consent obtained
Disqualifiers
Children with allergies or contraindications to the trial drugs (amoxicillin or amoxicillin + clavulanic acid)
Children with asthma or chronic obstructive pulmonary disease (COPD) (as per medical record)
Children who have received treatment with the trial drugs within the past month
Children already enrolled in other research programs or who have received trial treatment
Trial design
Treatments tested in this trial
- Amoxicillin
- Clavulanic Acid