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

PHASE3CompletedINTERVENTIONAL
Enrollment

902

Participants

Timeline

Start Date

January 31, 2003

Study Completion Date

May 31, 2004

Conditions
Acute Otitis Media
Interventions
DRUG

amoxicillin/clavulanate postassium (Augmentin ES-600)

amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days

DRUG

azithromycin SR

azithromycin SR 60 mg/kg x 1 dose

Trial Locations (48)

13419

Pfizer Investigational Site, Tallinn

15213

Pfizer Investigational Site, Pittsburgh

22180

Pfizer Investigational Site, Vienna

31020

Pfizer Investigational Site, Chihuahua City

31096

Pfizer Investigational Site, Haifa

40004

Pfizer Investigational Site, Bardstown

40069

Pfizer Investigational Site, Springfield

44310

Pfizer Investigational Site, Rakvere

49100

Pfizer Investigational Site, Petah Tikva

51014

Pfizer Investigational Site, Tartu

52621

Pfizer Investigational Site, Tel Litwinsky

60202

Pfizer Investigational Site, Evanston

60625

Pfizer Investigational Site, Chicago

60630

Pfizer Investigational Site, Chicago

71024

Pfizer Investigational Site, Pärsti Vald

72202

Pfizer Investigational Site, Little Rock

72401

Pfizer Investigational Site, Jonesboro

75234

Pfizer Investigational Site, Dallas

84651

Pfizer Investigational Site, Payson

84663

Pfizer Investigational Site, Springville

90660

Pfizer Investigational Site, Pico Rivera

90706

Pfizer Investigational Site, Bellflower

90723

Pfizer Investigational Site, Paramount

91321

Pfizer Investigational Site, Newhall

92647

Pfizer Investigational Site, Huntington Beach

92708

Pfizer Investigational Site, Fountain Valley

92868

Pfizer Investigational Site, Orange

93710

Pfizer Investigational Site, Fresno

93720

Pfizer Investigational Site, Fresno

117049

Pfizer Investigational Site, Moscow

123514

Pfizer Investigational Site, Moscow

214019

Pfizer Investigational Site, Smolensk

06606

Pfizer Investigational Site, Bridgeport

06106

Pfizer Investigational Site, Hartford

C1405DCR

Pfizer Investigational Site, Buenos Aires

Unknown

Pfizer Investigational Site, Independencia

Pfizer Investigational Site, Recoleta

Pfizer Investigational Site, Santiago

Pfizer Investigational Site, San José

Pfizer Investigational Site, Guatemala City

Pfizer Investigational Site, Jerusalem

Pfizer Investigational Site, Panama City

Pfizer Investigational Site

002

Pfizer Investigational Site, Santo Domingo

41-500

Pfizer Investigational Site, Chorzów

20-093

Pfizer Investigational Site, Lublin

040 11

Pfizer Investigational Site, Košice

036 01

Pfizer Investigational Site, Martin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY