Amoxicillin Clavulanate in Treatment of Acute Otitis Media

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-03-31

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.

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Detailed Description

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Conditions

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Acute Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.

Group Type EXPERIMENTAL

amoxicillin-clavulanate

Intervention Type DRUG

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.

2

Reconstituted placebo in 2 divided doses for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Interventions

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amoxicillin-clavulanate

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.

Intervention Type DRUG

Placebo

Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

Intervention Type DRUG

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

35 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No