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
Public ClinicalTrials.gov record NCT00643292. 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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT00643292
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 902 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Months to 48 Months
- 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 2003 (Type not available)
- Primary completion
- Not listed
- Completion
- May 2004 (Actual)
- Last update posted
- May 17, 2011
2003 – 2004
United States locations
- U.S. sites
- 23
- U.S. states
- 9
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pfizer Investigational Site | Jonesboro | Arkansas | 72401 | — |
| Pfizer Investigational Site | Little Rock | Arkansas | 72202 | — |
| Pfizer Investigational Site | Bellflower | California | 90706 | — |
| Pfizer Investigational Site | Fountain Valley | California | 92708 | — |
| Pfizer Investigational Site | Fresno | California | 93710 | — |
| Pfizer Investigational Site | Fresno | California | 93720 | — |
| Pfizer Investigational Site | Huntington Beach | California | 92647 | — |
| Pfizer Investigational Site | Newhall | California | 91321 | — |
| Pfizer Investigational Site | Orange | California | 92868 | — |
| Pfizer Investigational Site | Paramount | California | 90723 | — |
| Pfizer Investigational Site | Pico Rivera | California | 90660 | — |
| Pfizer Investigational Site | Bridgeport | Connecticut | 06606 | — |
| Pfizer Investigational Site | Hartford | Connecticut | 06106 | — |
| Pfizer Investigational Site | Chicago | Illinois | 60625 | — |
| Pfizer Investigational Site | Chicago | Illinois | 60630 | — |
| Pfizer Investigational Site | Evanston | Illinois | 60202 | — |
| Pfizer Investigational Site | Bardstown | Kentucky | 40004 | — |
| Pfizer Investigational Site | Springfield | Kentucky | 40069 | — |
| Pfizer Investigational Site | Pittsburgh | Pennsylvania | 15213 | — |
| Pfizer Investigational Site | Dallas | Texas | 75234 | — |
| Pfizer Investigational Site | Payson | Utah | 84651 | — |
| Pfizer Investigational Site | Springville | Utah | 84663 | — |
| Pfizer Investigational Site | 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.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 25 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00643292, 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 May 17, 2011 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00643292 live on ClinicalTrials.gov.