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
NCT ID: NCT00643292
Last Updated: 2011-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
902 participants
INTERVENTIONAL
2003-01-31
2004-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
amoxicillin/clavulanate postassium (Augmentin ES-600)
amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days
2
azithromycin SR
azithromycin SR 60 mg/kg x 1 dose
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
3 Months
48 Months
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Jonesboro, Arkansas, United States
Pfizer Investigational Site
Little Rock, Arkansas, United States
Pfizer Investigational Site
Bellflower, California, 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
Huntington Beach, California, 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
Pico Rivera, California, United States
Pfizer Investigational Site
Bridgeport, Connecticut, United States
Pfizer Investigational Site
Hartford, Connecticut, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Evanston, Illinois, United States
Pfizer Investigational Site
Bardstown, Kentucky, United States
Pfizer Investigational Site
Springfield, Kentucky, United States
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
Payson, Utah, United States
Pfizer Investigational Site
Springville, Utah, United States
Pfizer Investigational Site
Vienna, Virginia, United States
Pfizer Investigational Site
Buenos Aires, , Argentina
Pfizer Investigational Site
Independencia, Santiago Metropolitan, Chile
Pfizer Investigational Site
Recoleta, Santiago Metropolitan, Chile
Pfizer Investigational Site
Santiago, , Chile
Pfizer Investigational Site
San José, Provincia de San José, Costa Rica
Pfizer Investigational Site
Santo Domingo, DN, Dominican Republic
Pfizer Investigational Site
Pärsti Vald, Viljandimaa, Estonia
Pfizer Investigational Site
Rakvere, , Estonia
Pfizer Investigational Site
Tallinn, , Estonia
Pfizer Investigational Site
Tartu, , Estonia
Pfizer Investigational Site
Guatemala City, Departamento de Guatemala, Guatemala
Pfizer Investigational Site
Haifa, , Israel
Pfizer Investigational Site
Jerusalem, , Israel
Pfizer Investigational Site
Petah Tikva, , Israel
Pfizer Investigational Site
Tel Litwinsky, , Israel
Pfizer Investigational Site
Chihuahua City, Chihuahua, Mexico
Pfizer Investigational Site
Panama City, , Panama
Pfizer Investigational Site
Chorzów, , Poland
Pfizer Investigational Site
Lublin, , Poland
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Moscow, , Russia
Pfizer Investigational Site
Smolensk, , Russia
Pfizer Investigational Site
Košice, Slovakia, Slovakia
Pfizer Investigational Site
Martin, Slovakia, Slovakia
Pfizer Investigational Site
, ,
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0661073
Identifier Type: -
Identifier Source: org_study_id
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