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To compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cefdinir (Omnicef) | Drug | oral suspension, 7 mg/kg every 12 hours for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical cure rate at Evaluation 2 | 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained clinical cure rate at Evaluation 4 | 25 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbiana | Alabama | 35051 | United States | |||
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| azithromycin | Drug | oral suspension 10 mg/kg QD on Day 1 then 5 mg/kg QD on Days 2-5 for a total of 5 days. |
|
| Montgomery |
| Alabama |
| 36116 |
| United States |
| Ozark | Alabama | 36360 | United States |
| Fresno | California | 93710 | United States |
| Fresno | California | 93720 | United States |
| Marietta | Georgia | 30062 | United States |
| Stone Mountain | Georgia | 30087 | United States |
| Dubuque | Iowa | 52002 | United States |
| Bardstown | Kentucky | 40004 | United States |
| Louisville | Kentucky | 40207 | United States |
| Owensboro | Kentucky | 42303 | United States |
| Cadillac | Michigan | 49601 | United States |
| Kalamazoo | Michigan | 49008 | United States |
| Portage | Michigan | 49024 | United States |
| Richland | Michigan | 49083 | United States |
| Omaha | Nebraska | 68178 | United States |
| Columbus | Ohio | 43205 | United States |
| Huber Heights | Ohio | 45424 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Reading | Pennsylvania | 19606 | United States |
| Sellersville | Pennsylvania | 18960 | United States |
| Charleston | South Carolina | 29425 | United States |
| Kingsport | Tennessee | 37664 | United States |
| Lake Jackson | Texas | 77566 | United States |
| Salt Lake City | Utah | 84109 | United States |
| Salt Lake City | Utah | 84121 | United States |
| West Jordan | Utah | 84008 | United States |
| West Jordan | Utah | 84084 | United States |
| Vienna | Virginia | 22180 | United States |
| Monroe | Wisconsin | 53566 | United States |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000077525 | Cefdinir |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
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