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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
902

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2003

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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