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

Not Applicable

Not yet recruiting

• Conditions: Acute Otitis Media

• Registration Number: NCT06895135
• Lead Sponsor: University of Health Sciences Lahore

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-25
• Study First Posted: 2025-03-26
• Last Update Posted: 2025-03-30
• Study Start: 2025-05
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Symptom Resolution (in Days)	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.
Number of Participants with Treatment Failure	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.