Status:
COMPLETED
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
Lead Sponsor:
Pfizer
Conditions:
Acute Otitis Media
Eligibility:
All Genders
3-48 years
Phase:
PHASE3
Brief Summary
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 am...
Eligibility Criteria
Inclusion
- Outpatients with clinical evidence of acute otitis media who weigh at least 5 kg were included
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2004
Estimated Enrollment :
902 Patients enrolled
Trial Details
Trial ID
NCT00643292
Start Date
January 1 2003
End Date
May 1 2004
Last Update
May 17 2011
Active Locations (48)
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1
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
2
Pfizer Investigational Site
Little Rock, Arkansas, United States, 72202
3
Pfizer Investigational Site
Bellflower, California, United States, 90706
4
Pfizer Investigational Site
Fountain Valley, California, United States, 92708