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

Condition(s) targeted: Acute Otitis Media

Intervention: amoxicillin/clavulanate postassium (Augmentin ES-600) (Drug); azithromycin SR (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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 design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Secondary outcome:

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

Minimum age: 3 Months. Maximum age: 48 Months. Gender(s): Both.

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.

Pfizer Investigational Site, Buenos Aires C1405DCR, Argentina

Pfizer Investigational Site, Santiago, Chile

Pfizer Investigational Site, San Jose, Costa Rica

Pfizer Investigational Site, Tallinn 13419, Estonia

Pfizer Investigational Site, Tartu 51014, Estonia

Pfizer Investigational Site, Rakvere 44310, Estonia

Pfizer Investigational Site, Guatemala, Guatemala

Pfizer Investigational Site, JERUSALEM, Israel

Pfizer Investigational Site, Petach Tikva 49100, Israel

Pfizer Investigational Site, TEL HASHOMER 52621, Israel

Pfizer Investigational Site, Haifa 31096, Israel

Pfizer Investigational Site, Chihuahua 31020, Mexico

Pfizer Investigational Site, Ciudad de Panama, Panama

Pfizer Investigational Site, Chorzow 41-500, Poland

Pfizer Investigational Site, Lublin 20-093, Poland

Pfizer Investigational Site, Moscow 117049, Russian Federation

Pfizer Investigational Site, Smolensk 214019, Russian Federation

Pfizer Investigational Site, Moscow 123514, Russian Federation

Pfizer Investigational Site, Kosice 040 11, Slovakia

Pfizer Investigational Site, Martin 036 01, Slovakia

Pfizer Investigational Site, Jonesboro, Arkansas 72401, United States

Pfizer Investigational Site, Little Rock, Arkansas 72202, United States

Pfizer Investigational Site, Unknown, Buenos Aires C1425DEM, Argentina

Pfizer Investigational Site, FRESNO, California 93710, United States

Pfizer Investigational Site, Fresno, California 93720, United States

Pfizer Investigational Site, Bellflower, California 90706, United States

Pfizer Investigational Site, PARAMOUNT, California 90723, United States

Pfizer Investigational Site, Paramount, California 90723, United States

Pfizer Investigational Site, ORANGE, California 92868, United States

Pfizer Investigational Site, Fountain Valley, California 92708, United States

Pfizer Investigational Site, Huntington Beach, California 92647, United States

Pfizer Investigational Site, Pico Rivera, California 90660, United States

Pfizer Investigational Site, Newhall, California 91321, United States

Pfizer Investigational Site, Bridgeport, Connecticut 06606, United States

Pfizer Investigational Site, Hartford, Connecticut 06106, United States

Pfizer Investigational Site, Unknown, Córdoba X5000BJH, Argentina

Pfizer Investigational Site, Santo Domingo, DN 002, Dominican Republic

Pfizer Investigational Site, CHICAGO, Illinois 60630, United States

Pfizer Investigational Site, Chicago, Illinois 60625, United States

Pfizer Investigational Site, EVANSTON, Illinois 60202, United States

Pfizer Investigational Site, Bardstown, Kentucky 40004, United States

Pfizer Investigational Site, Springfield, Kentucky 40069, United States

Pfizer Investigational Site, PITTSBURGH, Pennsylvania 15213, United States

Pfizer Investigational Site, Recoleta, Santiago, Chile

Pfizer Investigational Site, Independencia, Santiago, Chile

Pfizer Investigational Site, Dallas, Texas 75234, United States

Pfizer Investigational Site, Payson, Utah 84651, United States

Pfizer Investigational Site, Springville, Utah 84663, United States

Pfizer Investigational Site, Pärsti vald, Viljandimaa 71024, Estonia

Pfizer Investigational Site, Vienna, Virginia 22180, United States

To obtain contact information for a study center near you, click here.

Starting date: January 2003
Ending date: May 2004
Last updated: March 19, 2008