Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children

Launched by UNIVERSITY OF HEALTH SCIENCES LAHORE · Mar 18, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to find out which treatment works better for young children with a common ear infection called acute otitis media, or middle ear infection. They are comparing two options: one group of children will receive amoxicillin alone, while another group will get a combination of amoxicillin and clavulanic acid. The goal is to see which treatment helps children recover faster and reduces the chances of the infection coming back or not getting better at all. This research is important because it will help doctors make better choices when treating children with this infection.

To be eligible for the trial, children must be between the ages of 1 and 5 years and have been diagnosed with acute otitis media. Both boys and girls can participate, but parents will need to give their consent. However, children who have certain allergies, respiratory conditions like asthma, or who have recently received similar treatments may not be able to join. The trial is not currently recruiting participants yet, but it is designed to provide valuable information for treating ear infections in young kids. If a child is chosen to participate, their caregivers can expect to be involved in monitoring their treatment and recovery process.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children aged 1 to 5 years
• • Diagnosed with acute otitis media (as per operational definition)
• • Both male and female participants
• • Parental consent obtained
• Exclusion Criteria:
• • 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
• • Children with any comorbid conditions that may interfere with the study