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Amoxicillin vs. Amoxicillin Plus Clavulanic Acid for Acute Otitis Media in Children

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What is being tested

Amoxicillin

+ Clavulanic Acid

Other
Who is being recruted

Ear Diseases+1

+ Otitis

+ Otitis Media

From 1 to 5 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2025
See protocol details

Summary

Principal SponsorUniversity of Health Sciences Lahore
Study ContactMuhammad Arslan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2025

Actual date on which the first participant was enrolled.

The study focuses on examining the effectiveness of two different antibiotic treatments for children aged 1 to 5 years who have acute otitis media, a common ear infection. This infection can cause discomfort, fever, and even temporary hearing issues in children. Researchers are comparing the use of amoxicillin alone versus a combination of amoxicillin with clavulanic acid to see which treatment works better. By understanding which treatment is more effective, the study aims to improve how this common ear infection is treated in young children, potentially leading to faster recoveries and fewer complications. Participants in the study are randomly divided into two groups. One group receives amoxicillin, while the other receives the combination of amoxicillin and clavulanic acid. The study is conducted at Nishtar Hospital, Multan, and involves closely monitoring the children to see how quickly their symptoms improve, if the infection comes back, or if they experience any side effects. The results of the study are carefully analyzed to determine which treatment option is more effective in resolving symptoms faster and with fewer issues. This research could play a crucial role in guiding healthcare providers on the best treatment options for children with this ear infection.

Official TitleComparison of Efficacy of Amoxicillin Plus Clavulanic Acid and Amoxicillin in Children with Acute Otitis Media
NCT06895135
Principal SponsorUniversity of Health Sciences Lahore
Study ContactMuhammad Arslan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

162 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 5 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Ear DiseasesOtitisOtitis MediaOtorhinolaryngologic Diseases

Criteria

4 inclusion criteria required to participate
Children aged 1 to 5 years
Diagnosed with acute otitis media (as per operational definition)
Both male and female participants
Parental consent obtained
5 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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.

Group II

Active Comparator
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.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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