Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Amoxicillin, Clavulanic Acid.
- Who it may be relevant to
- Registry conditions: Acute Otitis Media. Basic parameters: 1 year — 5 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Efficacy of Amoxicillin Plus Clavulanic Acid and Amoxicillin in Children with Acute Otitis Media
Overview
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.
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.
Primary outcome measures
- 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.]
- Number of Participants with Treatment Failure [Time frame: Assessed at 4 weeks from the start of treatment.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06895135 · Exp130