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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversity of Health Sciences Lahore

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

Treatment groups

162 Participants
are divided into 2 treatment groups

Locations

This trial has no locations