Amoxicillin Clavulanate in Treatment of Acute Otitis Media

February 10, 2009 updated by: University of Turku

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland
      • Turku, Finland, 20521
        • Department of Pediatrics, Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 2 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Reconstituted amoxicillin-clavulanate at 40/5.7 mg/kg/day in 2 divided doses for 7 days.
Drug: 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.
PLACEBO_COMPARATOR: 2
Reconstituted placebo in 2 divided doses for 7 days.
Drug: Placebo
Placebo twice a day for 7 days. Placebo capsules contain lactose monohydrate 640 mg.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to resolution of symptoms in children receiving amoxicillin-clavulanate to children receiving placebo
Time Frame: Duration of study
Duration of study
Time to resolution of acute inflammatory signs of middle ear
Time Frame: Duration of study
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
Time Frame: First 7 days of follow-up
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
Time Frame: First 7 days of follow-up
First 7 days of follow-up
Compare the incidence of adverse events accompanying the 2 treatment regimens
Time Frame: Duration of study
Duration of study
Time to resolution of middle ear fluid in the ear(s) that is affected on study day 1
Time Frame: Duration of study
Duration of study
Time to relapse of acute otitis media
Time Frame: Study days 9-17
Study days 9-17
Time to first reinfection of acute otitis media
Time Frame: From study day 18 to the end of follow-up
From study day 18 to the end of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Turku

Collaborators

Finnish Institute for Health and Welfare

Investigators

  • Principal Investigator: Aino Ruohola, MD, PhD, Pediatrician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ANTICIPATED)

March 1, 2009

Study Registration Dates

First Submitted

March 3, 2006

First Submitted That Met QC Criteria

March 3, 2006

First Posted (ESTIMATE)

March 6, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2009

Last Update Submitted That Met QC Criteria

February 10, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRR-60

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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