A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
Public ClinicalTrials.gov record NCT00644943. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.
Study identification
- NCT ID
- NCT00644943
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 425 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 6 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 31, 2003
- Primary completion
- Mar 31, 2003
- Completion
- Not listed
- Last update posted
- Mar 26, 2008
Started 2003
United States locations
- U.S. sites
- 32
- U.S. states
- 19
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Birmingham | Alabama | 35211 | — |
| Not listed | Montgomery | Alabama | 36116 | — |
| Not listed | Ozark | Alabama | 36360 | — |
| Not listed | Mesa | Arizona | 85201 | — |
| Not listed | Scottsdale | Arizona | 85251 | — |
| Not listed | Little Rock | Arkansas | 72211 | — |
| Not listed | Clovis | California | 93612 | — |
| Not listed | Fresno | California | 93270 | — |
| Not listed | Longmont | Colorado | 80501 | — |
| Not listed | Fairfield | Connecticut | 06430 | — |
| Not listed | Marietta | Georgia | 30062 | — |
| Not listed | Stone Mountain | Georgia | 30087 | — |
| Not listed | Bardstown | Kentucky | 40004 | — |
| Not listed | Louisville | Kentucky | 40207 | — |
| Not listed | Owensboro | Kentucky | 42301 | — |
| Not listed | Ruston | Louisiana | 71270 | — |
| Not listed | Shreveport | Louisiana | 71105 | — |
| Not listed | Kalamazoo | Michigan | 49008 | — |
| Not listed | Richland | Michigan | 49083 | — |
| Not listed | Omaha | Nebraska | 68178 | — |
| Not listed | Las Vegas | Nevada | 89104 | — |
| Not listed | Columbus | Ohio | 43205 | — |
| Not listed | Medford | Oregon | 97504 | — |
| Not listed | Pittsburgh | Pennsylvania | 15241 | — |
| Not listed | Sellersville | Pennsylvania | 18960 | — |
| Not listed | Charleston | South Carolina | 29403 | — |
| Not listed | Austin | Texas | 78758 | — |
| Not listed | Lake Jackson | Texas | 77566 | — |
| Not listed | Salt Lake City | Utah | 84109 | — |
| Not listed | Salt Lake City | Utah | 84121 | — |
| Not listed | West Jordan | Utah | 84084 | — |
| Not listed | Vienna | Virginia | 22180 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00644943, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 26, 2008 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00644943 live on ClinicalTrials.gov.