Amoxicillin Clavulanate in Treatment of Acute Otitis Media

Study Overview
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Brief Summary
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This is a prospective, randomized, double-blind, placebo controlled one-center study carried out in primary care setting of the health center of City of Turku, Finland. The study patients will be allocated to one of the two parallel treatment groups (amoxicillin-clavulanate or placebo). The hypothesis is that the symptoms and signs of acute otitis media are resolved more effectively with antimicrobial treatment than with placebo. Furthermore, this study aims at finding out prognostic factors that could help to direct antimicrobial treatment for correct subgroups of young patients.

Official Title
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Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children

Conditions
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Acute Otitis Media

Intervention / Treatment
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* Drug: amoxicillin-clavulanate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute otitis media Age 6 - 35 mo Exclusion Criteria: Spontaneous perforation of the tympanic membrane and drainage Systemic or nasal corticosteroid therapy within 3 preceding days Antihistamine therapy with 3 preceding days Oseltamivir therapy within 3 preceding days Allergy to amoxicillin/penicillin Tympanostomy tube present in tympanic membrane Clinical evidence of infection requiring systemic antimicrobial treatment Documented Ebstein Barr virus infection within 7 preceding days Down syndrome or other condition to affect middle ear infections Known immunodeficiency Vomiting or another symptom to violate per oral dosage Poor parental co-operation due to language or other reasons Use of any investigational drugs during the 4 preceding weeks

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 35 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days. | Drug: amoxicillin-clavulanate<br>* Amoxicillin clavulanate 40 mg/kg/day divided into two daily doses for 7 days. Capsules will be produced by pulverizing amoxicillin clavulanate tablets (Augmentin 875 mg; manufacturer Glaxo SmithKline Beecham; ATC Code: J01CR02) and mixing that with lactose monohydrate. Each capsule will contain Augmentin tablet powder 68 mg and lactose monohydrate 572 mg. This means amoxicillin 40 mg and clavulanate 5,7 mg respecting the dose per 2 kg.<br>|
| Placebo Comparator: 2<br>Reconstituted placebo in 2 divided doses for 7 days. | Drug: Placebo<br>* Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare time to treatment failure in children receiving amoxicillin-clavulanate to children receiving placebo |  | During the first 8 days of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo |  | Duration of study | 
| Time to resolution of acute inflammatory signs of middle ear |  | Duration of study | 
| Compare the 2 treatment groups regarding the doses of analgesic medication and number of days analgesics are administered by children's parents |  | First 7 days of follow-up | 
| Compare the 2 treatment groups regarding the number of days with absenteeism from day care and/or parental absenteeism from work |  | First 7 days of follow-up | 
| Compare the incidence of adverse events accompanying the 2 treatment regimens |  | Duration of study | 
| Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1 |  | Duration of study | 
| Time to relapse of acute otitis media |  | Study days 9-17 | 
| Time to first reinfection of acute otitis media |  | From study day 18 to the end of follow-up |