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
Completed · Phase 3
Conditions studied: Acute Otitis Media
In brief
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
Key facts
- Study ID
- NCT00643292
- Run by
- Pfizer
- People needed
- 902
- Starts
- 2003-01-01
- Expected to finish
- 2004-05-01
- Last updated by the study team
- 2011-05-17
Who can join
Age: 0 and older, up to 4. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included
You may not qualify if…
- 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.
Where it is running
- Pfizer Investigational Site — Jonesboro, Arkansas, United States
- Pfizer Investigational Site — Little Rock, Arkansas, United States
- Pfizer Investigational Site — Bellflower, California, 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 — Huntington Beach, California, 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 — Pico Rivera, California, United States
- Pfizer Investigational Site — Bridgeport, Connecticut, United States
- Pfizer Investigational Site — Hartford, Connecticut, United States
- Pfizer Investigational Site — Chicago, Illinois, United States
- Pfizer Investigational Site — Chicago, Illinois, United States
- Pfizer Investigational Site — Evanston, Illinois, United States
- Pfizer Investigational Site — Bardstown, Kentucky, United States
- Pfizer Investigational Site — Springfield, Kentucky, United States
- Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
- Pfizer Investigational Site — Dallas, Texas, United States
- Pfizer Investigational Site — Payson, Utah, United States
- Pfizer Investigational Site — Springville, Utah, United States
- Pfizer Investigational Site — Vienna, Virginia, United States
- Pfizer Investigational Site — Buenos Aires, Argentina
- Pfizer Investigational Site — Independencia, Santiago Metropolitan, Chile
Full record on ClinicalTrials.gov
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