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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

Primary Purpose

Acute Otitis Media

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
amoxicillin/clavulanate postassium (Augmentin ES-600)
azithromycin SR
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Otitis Media

Eligibility Criteria

3 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
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  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

clinical response (cure or failure) in the Clinical Per Protocol population

Secondary Outcome Measures

summary of baseline susceptibilities
clinical response (cure or failure) in the Clinical Per Protocol population
Laboratory abnormalities
bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population
adverse events
clinical response (cure or failure) in all populations except the Clinical Per Protocol population
clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population
clinical response (cure or failure) in the Clinical Per Protocol population
clinical scores for the Clinical Per Protocol population
persistence of middle ear fluid for the Clinical Per Protocol population
audiologic response

Full Information

First Posted
March 19, 2008
Last Updated
May 16, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00643292
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
902 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
amoxicillin/clavulanate postassium (Augmentin ES-600)
Intervention Description
amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
Intervention Type
Drug
Intervention Name(s)
azithromycin SR
Intervention Description
azithromycin SR 60 mg/kg x 1 dose
Primary Outcome Measure Information:
Title
clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame
Test of Cure (TOC) visit (Day 12-14)
Secondary Outcome Measure Information:
Title
summary of baseline susceptibilities
Time Frame
Study endpoint
Title
clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame
On-Treatment (OT) visit (Day 4-6)
Title
Laboratory abnormalities
Time Frame
Baseline and TOC visit
Title
bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population
Time Frame
TOC visit
Title
adverse events
Time Frame
Continuous
Title
clinical response (cure or failure) in all populations except the Clinical Per Protocol population
Time Frame
OT visit and TOC visit
Title
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)
Title
clinical response (cure or failure) in the Clinical Per Protocol population
Time Frame
LTFU visit
Title
clinical scores for the Clinical Per Protocol population
Time Frame
OT visit and TOC visit
Title
persistence of middle ear fluid for the Clinical Per Protocol population
Time Frame
TOC visit and LTFU visit
Title
audiologic response
Time Frame
LTFU visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Pfizer Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Pfizer Investigational Site
City
Bellflower
State/Province
California
ZIP/Postal Code
90706
Country
United States
Facility Name
Pfizer Investigational Site
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Pfizer Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Pfizer Investigational Site
City
Newhall
State/Province
California
ZIP/Postal Code
91321
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pfizer Investigational Site
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Pfizer Investigational Site
City
Pico Rivera
State/Province
California
ZIP/Postal Code
90660
Country
United States
Facility Name
Pfizer Investigational Site
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Pfizer Investigational Site
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60625
Country
United States
Facility Name
Pfizer Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60630
Country
United States
Facility Name
Pfizer Investigational Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States
Facility Name
Pfizer Investigational Site
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
Pfizer Investigational Site
City
Springfield
State/Province
Kentucky
ZIP/Postal Code
40069
Country
United States
Facility Name
Pfizer Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Pfizer Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Pfizer Investigational Site
City
Payson
State/Province
Utah
ZIP/Postal Code
84651
Country
United States
Facility Name
Pfizer Investigational Site
City
Springville
State/Province
Utah
ZIP/Postal Code
84663
Country
United States
Facility Name
Pfizer Investigational Site
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22180
Country
United States
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1405DCR
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Independencia
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Recoleta
State/Province
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
Santiago
Country
Chile
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Santo Domingo
State/Province
DN
ZIP/Postal Code
002
Country
Dominican Republic
Facility Name
Pfizer Investigational Site
City
Pärsti vald
State/Province
Viljandimaa
ZIP/Postal Code
71024
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Rakvere
ZIP/Postal Code
44310
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Pfizer Investigational Site
City
Guatemala
Country
Guatemala
Facility Name
Pfizer Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Pfizer Investigational Site
City
Jerusalem
Country
Israel
Facility Name
Pfizer Investigational Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Pfizer Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Pfizer Investigational Site
City
Chihuahua
ZIP/Postal Code
31020
Country
Mexico
Facility Name
Pfizer Investigational Site
City
Ciudad de Panama
Country
Panama
Facility Name
Pfizer Investigational Site
City
Chorzow
ZIP/Postal Code
41-500
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
117049
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Moscow
ZIP/Postal Code
123514
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661073&StudyName=A%20Single%2C%20High-Dose%20Azithromycin%20Extended%20Release%20%2860%20mg/kg%29%20Compared%20with%2010%20Days%20of%20High-Dose%20Amoxicillin%20Clavulanate%20in%20Children%20
Description
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Learn more about this trial

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

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