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

March 25, 2025 updated by: Muhammad Arslan, University of Health Sciences Lahore

Comparison of Efficacy of Amoxicillin Plus Clavulanic Acid and Amoxicillin in Children with Acute Otitis Media

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the effectiveness of two antibiotic treatments in children diagnosed with acute otitis media, a common ear infection. The two treatments being compared are amoxicillin alone and a combination of amoxicillin and clavulanic acid. Acute otitis media is a significant health concern in children, causing pain, fever, and possible hearing loss.

The study will be conducted as a randomized controlled trial at the Department of Pediatric Medicine, Nishtar Hospital, Multan. A total of 162 children, aged 1 to 5 years, will be enrolled in the study. They will be randomly assigned to one of two treatment groups: one group will receive amoxicillin, and the other group will receive amoxicillin plus clavulanic acid. The children will be monitored throughout their treatment to assess how quickly their symptoms resolve, whether they experience treatment failure or recurrence, and if they develop any side effects.

The study aims to provide clearer evidence on the efficacy of the combination treatment (amoxicillin + clavulanic acid) compared to amoxicillin alone. By analyzing treatment outcomes such as symptom resolution time, side effects, and recurrence, the study will help inform clinical decisions and improve treatment protocols for acute otitis media in pediatric patients. The data will be analyzed using statistical software to determine whether the combination therapy leads to faster recovery and fewer complications. The findings from this study will contribute to better management of upper respiratory infections in children.

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amoxicillin Treatment Group
Participants in this arm will receive oral amoxicillin at a dose of 30mg/kg/day. They will be monitored for the resolution of symptoms, treatment failure, recurrence, and potential side effects over the course of the study.
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.
Active Comparator: Amoxicillin + Clavulanic Acid Treatment Group
Participants in this arm will receive oral amoxicillin combined with clavulanic acid at a dose of 30mg/kg/day. Like the other group, they will be monitored for symptom resolution, treatment failure, recurrence, and side effects throughout the study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Symptom Resolution (in Days)
Time Frame: From enrollment to the resolution of symptoms, assessed daily until symptoms are resolved, up to a maximum of 4 weeks.

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.
From enrollment to the resolution of symptoms, assessed daily until symptoms are resolved, up to a maximum of 4 weeks.
Number of Participants with Treatment Failure
Time Frame: Assessed at 4 weeks from the start of treatment.
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.
Assessed at 4 weeks from the start of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Health Sciences Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2025

Last Update Submitted That Met QC Criteria

March 25, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exp130

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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