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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| amoxicillin/clavulanate postassium (Augmentin ES-600) | Drug | amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical response (cure or failure) in the Clinical Per Protocol population | Test of Cure (TOC) visit (Day 12-14) |
| Measure | Description | Time Frame |
|---|---|---|
| summary of baseline susceptibilities | Study endpoint | |
| clinical response (cure or failure) in the Clinical Per Protocol population | On-Treatment (OT) visit (Day 4-6) | |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Jonesboro | Arkansas | 72401 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| azithromycin SR | Drug | azithromycin SR 60 mg/kg x 1 dose |
|
| Laboratory abnormalities |
| Baseline and TOC visit |
| bacteriological response (eradication, presumed eradication, persistence, or presumed persistence) on a per pathogen basis for the Bacteriological Per Protocol population | TOC visit |
| adverse events | Continuous |
| clinical response (cure or failure) in all populations except the Clinical Per Protocol population | OT visit and TOC visit |
| 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) |
| clinical response (cure or failure) in the Clinical Per Protocol population | LTFU visit |
| clinical scores for the Clinical Per Protocol population | OT visit and TOC visit |
| persistence of middle ear fluid for the Clinical Per Protocol population | TOC visit and LTFU visit |
| audiologic response | LTFU visit |
| Little Rock |
| Arkansas |
| 72202 |
| United States |
| Pfizer Investigational Site | Bellflower | California | 90706 | United States |
| Pfizer Investigational Site | Fountain Valley | California | 92708 | United States |
| Pfizer Investigational Site | Fresno | California | 93710 | United States |
| Pfizer Investigational Site | Fresno | California | 93720 | United States |
| Pfizer Investigational Site | Huntington Beach | California | 92647 | United States |
| Pfizer Investigational Site | Newhall | California | 91321 | United States |
| Pfizer Investigational Site | Orange | California | 92868 | United States |
| Pfizer Investigational Site | Paramount | California | 90723 | United States |
| Pfizer Investigational Site | Pico Rivera | California | 90660 | United States |
| Pfizer Investigational Site | Bridgeport | Connecticut | 06606 | United States |
| Pfizer Investigational Site | Hartford | Connecticut | 06106 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60625 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60630 | 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 | Dallas | Texas | 75234 | United States |
| Pfizer Investigational Site | Payson | Utah | 84651 | United States |
| Pfizer Investigational Site | Springville | Utah | 84663 | United States |
| Pfizer Investigational Site | Vienna | Virginia | 22180 | United States |
| Pfizer Investigational Site | Buenos Aires | C1405DCR | 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 | 002 | Dominican Republic |
| Pfizer Investigational Site | Pärsti Vald | Viljandimaa | 71024 | Estonia |
| Pfizer Investigational Site | Rakvere | 44310 | Estonia |
| Pfizer Investigational Site | Tallinn | 13419 | Estonia |
| Pfizer Investigational Site | Tartu | 51014 | Estonia |
| Pfizer Investigational Site | Guatemala City | Departamento de Guatemala | Guatemala |
| Pfizer Investigational Site | Haifa | 31096 | Israel |
| Pfizer Investigational Site | Jerusalem | Israel |
| Pfizer Investigational Site | Petah Tikva | 49100 | Israel |
| Pfizer Investigational Site | Tel Litwinsky | 52621 | Israel |
| Pfizer Investigational Site | Chihuahua City | Chihuahua | 31020 | Mexico |
| Pfizer Investigational Site | Panama City | Panama |
| Pfizer Investigational Site | Chorzów | 41-500 | Poland |
| Pfizer Investigational Site | Lublin | 20-093 | Poland |
| Pfizer Investigational Site | Moscow | 117049 | Russia |
| Pfizer Investigational Site | Moscow | 123514 | Russia |
| Pfizer Investigational Site | Smolensk | 214019 | Russia |
| Pfizer Investigational Site | Košice | Slovakia | 040 11 | Slovakia |
| Pfizer Investigational Site | Martin | Slovakia | 036 01 | Slovakia |
| Pfizer Investigational Site |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000658 | Amoxicillin |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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