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.
Children aged 1 to 5 years
Diagnosed with acute otitis media (as per operational definition)
Both male and female participants
Parental consent obtained
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
Parallel
Amoxicillin
Other interventionParticipants in this group will receive oral amoxicillin at a dosage of 30mg/kg/day. The treatment will be administered in divided doses for the duration of the study, with the aim of resolving symptoms of acute otitis media in children.
Clavulanic Acid
Other interventionParticipants in this group will receive a combination of oral amoxicillin and clavulanic acid at a dosage of 30mg/kg/day. The medication will be given in divided doses, and participants will be monitored for symptom resolution and any potential side effects.
Time to Symptom Resolution (in Days)
How Measured: The number of days it takes for the symptoms of acute otitis media (fever, ear pain, bulging tympanic membrane) to completely resolve after starting treatment will be recorded. Participants will be assessed daily until the resolution of symptoms. The assessment will be made by the treating physician based on clinical signs observed through otoscopy and patient-reported outcomes (such as pain relief). Criteria for Resolution: Symptoms are considered resolved when the child no longer experiences ear pain, fever, or any other signs of infection. The tympanic membrane will appear normal during otoscopy, with no visible bulging or signs of fluid accumulation.
Number of Participants with Treatment Failure
Treatment failure is defined as the failure to resolve symptoms within 4 weeks of starting treatment. If symptoms persist or worsen despite the antibiotic treatment, the physician will classify the case as treatment failure and change the antibiotic regimen.
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