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

NCT06895135 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2025-03-30

No results posted yet for this study

Summary

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.

Conditions

  • Acute Otitis Media

Interventions

OTHER

Amoxicillin

Participants 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.

OTHER

Clavulanic Acid

Participants 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.

Sponsors & Collaborators

  • University of Health Sciences Lahore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-05-31
Completion
2026-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06895135 on ClinicalTrials.gov