Acute Otitis Media Clinical Trial
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
Verified date | May 2011 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Argentina, Chile, Costa Rica, Dominican Republic, Estonia, Guatemala, Israel, Mexico, Panama, Poland, Russian Federation, Slovakia,
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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