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

NCT06895135 | Not Yet Recruiting

• 1 other identifier: Exp130
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

Study Arms (2)

Amoxicillin Treatment Group

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.

Other: Amoxicillin

Amoxicillin + Clavulanic Acid Treatment Group

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.

Other: Amoxicillin; Other: Clavulanic Acid

Interventions

Amoxicillin OTHER

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.

Amoxicillin + Clavulanic Acid Treatment Group; Amoxicillin Treatment Group

Clavulanic Acid OTHER

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.

Amoxicillin + Clavulanic Acid Treatment Group

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 to 5 years
• Diagnosed with acute otitis media (as per operational definition)
• Both male and female participants
• Parental consent obtained

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Health Sciences Lahore: lead

MeSH Terms

Conditions

Otitis Media

Interventions

Amoxicillin; Clavulanic Acid

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Clavulanic Acids

Central Study Contacts

Muhammad Arslan

CONTACT

03106717292; drmuhammadarslan1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 26, 2025
• Study Start: May 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 30, 2025

Record last verified: 2025-03