A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections

May 16, 2011 updated by: Pfizer

A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Amoxicillin/Clavulanate Potassium (Augmentin ES-600 Trademark) for the Treatment of Acute Otitis Media in Children Undergoing Diagnostic Tympanocentesis

A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy, safety, and compliance of a single dose of azithromycin extended release compared with a 10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent or recurrent ear infections

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

902

Phase

  • Phase 3

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

        • Pfizer Investigational Site
  • Argentina
      • Buenos Aires, Argentina, C1405DCR
        • Pfizer Investigational Site
  • Chile
      • Santiago, Chile
        • Pfizer Investigational Site
    • Santiago
      • Independencia, Santiago, Chile
        • Pfizer Investigational Site
      • Recoleta, Santiago, Chile
        • Pfizer Investigational Site
  • Costa Rica
      • San Jose, Costa Rica
        • Pfizer Investigational Site
  • Dominican Republic
    • DN
      • Santo Domingo, DN, Dominican Republic, 002
        • Pfizer Investigational Site
  • Estonia
      • Rakvere, Estonia, 44310
        • Pfizer Investigational Site
      • Tallinn, Estonia, 13419
        • Pfizer Investigational Site
      • Tartu, Estonia, 51014
        • Pfizer Investigational Site
    • Viljandimaa
      • Pärsti vald, Viljandimaa, Estonia, 71024
        • Pfizer Investigational Site
  • Guatemala
      • Guatemala, Guatemala
        • Pfizer Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • Pfizer Investigational Site
      • Jerusalem, Israel
        • Pfizer Investigational Site
      • Petach Tikva, Israel, 49100
        • Pfizer Investigational Site
      • Tel Hashomer, Israel, 52621
        • Pfizer Investigational Site
  • Mexico
      • Chihuahua, Mexico, 31020
        • Pfizer Investigational Site
  • Panama
      • Ciudad de Panama, Panama
        • Pfizer Investigational Site
  • Poland
      • Chorzow, Poland, 41-500
        • Pfizer Investigational Site
      • Lublin, Poland, 20-093
        • Pfizer Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 117049
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 123514
        • Pfizer Investigational Site
      • Smolensk, Russian Federation, 214019
        • Pfizer Investigational Site
  • Slovakia
      • Kosice, Slovakia, 040 11
        • Pfizer Investigational Site
      • Martin, Slovakia, 036 01
        • Pfizer Investigational Site
  • United States
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • Pfizer Investigational Site
      • Little Rock, Arkansas, United States, 72202
        • Pfizer Investigational Site
    • California
      • Bellflower, California, United States, 90706
        • Pfizer Investigational Site
      • Fountain Valley, California, United States, 92708
        • Pfizer Investigational Site
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Fresno, California, United States, 93710
        • Pfizer Investigational Site
      • Huntington Beach, California, United States, 92647
        • Pfizer Investigational Site
      • Newhall, California, United States, 91321
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • Paramount, California, United States, 90723
        • Pfizer Investigational Site
      • Pico Rivera, California, United States, 90660
        • Pfizer Investigational Site
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Pfizer Investigational Site
      • Hartford, Connecticut, United States, 06106
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60630
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60625
        • Pfizer Investigational Site
      • Evanston, Illinois, United States, 60202
        • Pfizer Investigational Site
    • Kentucky
      • Bardstown, Kentucky, United States, 40004
        • Pfizer Investigational Site
      • Springfield, Kentucky, United States, 40069
        • Pfizer Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75234
        • Pfizer Investigational Site
    • Utah
      • Payson, Utah, United States, 84651
        • Pfizer Investigational Site
      • Springville, Utah, United States, 84663
        • Pfizer Investigational Site
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Pfizer Investigational Site

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

3 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included

Exclusion Criteria:

Patients with previously diagnosed disease of immune function, treatment with any systemic antibiotic within the previous 7 days, or cleft lip/palate or other anatomic abnormality predisposing to otitis media were excluded.

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: amoxicillin/clavulanate postassium (Augmentin ES-600)
amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
Experimental: 2
Drug: azithromycin SR
azithromycin SR 60 mg/kg x 1 dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame: Test of Cure (TOC) visit (Day 12-14)
Test of Cure (TOC) visit (Day 12-14)

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: Continuous
Continuous
summary of baseline susceptibilities
Time Frame: Study endpoint
Study endpoint
clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame: On-Treatment (OT) visit (Day 4-6)
On-Treatment (OT) visit (Day 4-6)
Laboratory abnormalities
Time Frame: Baseline and TOC visit
Baseline and TOC visit
bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population
Time Frame: TOC visit
TOC visit
clinical response (cure or failure) in all populations except the Clinical Per Protocol population
Time Frame: OT visit and TOC visit
OT visit and TOC visit
clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population
Time Frame: OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)
OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32)
clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame: LTFU visit
LTFU visit
clinical scores for the Clinical Per Protocol population
Time Frame: OT visit and TOC visit
OT visit and TOC visit
persistence of middle ear fluid for the Clinical Per Protocol population
Time Frame: TOC visit and LTFU visit
TOC visit and LTFU visit
audiologic response
Time Frame: LTFU visit
LTFU visit

Collaborators and Investigators

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

Sponsor

Pfizer

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.

Helpful Links

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

January 1, 2003

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 17, 2011

Last Update Submitted That Met QC Criteria

May 16, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0661073

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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