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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00643292
Other study ID # A0661073
Secondary ID
Status Completed
Phase Phase 3
First received March 19, 2008
Last updated May 16, 2011
Start date January 2003
Est. completion date May 2004

Study information

Verified date May 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 902
Est. completion date May 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 48 Months
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Unknown Buenos Aires
Argentina Pfizer Investigational Site Unknown Córdoba
Chile Pfizer Investigational Site Independencia Santiago
Chile Pfizer Investigational Site Recoleta Santiago
Chile Pfizer Investigational Site Santiago
Costa Rica Pfizer Investigational Site San Jose
Dominican Republic Pfizer Investigational Site Santo Domingo DN
Estonia Pfizer Investigational Site Pärsti vald Viljandimaa
Estonia Pfizer Investigational Site Rakvere
Estonia Pfizer Investigational Site Tallinn
Estonia Pfizer Investigational Site Tartu
Guatemala Pfizer Investigational Site Guatemala
Israel Pfizer Investigational Site Haifa
Israel Pfizer Investigational Site Jerusalem
Israel Pfizer Investigational Site Petach Tikva
Israel Pfizer Investigational Site Tel Hashomer
Mexico Pfizer Investigational Site Chihuahua
Panama Pfizer Investigational Site Ciudad de Panama
Poland Pfizer Investigational Site Chorzow
Poland Pfizer Investigational Site Lublin
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Moscow
Russian Federation Pfizer Investigational Site Smolensk
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Martin
United States Pfizer Investigational Site Bardstown Kentucky
United States Pfizer Investigational Site Bellflower California
United States Pfizer Investigational Site Bridgeport Connecticut
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Evanston Illinois
United States Pfizer Investigational Site Fountain Valley California
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Hartford Connecticut
United States Pfizer Investigational Site Huntington Beach California
United States Pfizer Investigational Site Jonesboro Arkansas
United States Pfizer Investigational Site Little Rock Arkansas
United States Pfizer Investigational Site Newhall California
United States Pfizer Investigational Site Orange California
United States Pfizer Investigational Site Paramount California
United States Pfizer Investigational Site Payson Utah
United States Pfizer Investigational Site Pico Rivera California
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Springfield Kentucky
United States Pfizer Investigational Site Springville Utah
United States Pfizer Investigational Site Vienna Virginia

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Costa Rica,  Dominican Republic,  Estonia,  Guatemala,  Israel,  Mexico,  Panama,  Poland,  Russian Federation,  Slovakia, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical response (cure or failure) in the Clinical Per Protocol population Test of Cure (TOC) visit (Day 12-14) No
Secondary summary of baseline susceptibilities Study endpoint No
Secondary clinical response (cure or failure) in the Clinical Per Protocol population On-Treatment (OT) visit (Day 4-6) No
Secondary Laboratory abnormalities Baseline and TOC visit Yes
Secondary bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population TOC visit No
Secondary adverse events Continuous Yes
Secondary clinical response (cure or failure) in all populations except the Clinical Per Protocol population OT visit and TOC visit No
Secondary clinical response (cure or failure) by baseline pathogen for the Bacteriological Per Protocol population OT visit, TOC visit, and Long-Term Follow-up (LTFU) visit (Day 28-32) No
Secondary clinical response (cure or failure) in the Clinical Per Protocol population LTFU visit No
Secondary clinical scores for the Clinical Per Protocol population OT visit and TOC visit No
Secondary persistence of middle ear fluid for the Clinical Per Protocol population TOC visit and LTFU visit No
Secondary audiologic response LTFU visit No
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