Status:
COMPLETED
A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
Lead Sponsor:
Pfizer
Conditions:
Tonsillitis
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used...
Eligibility Criteria
Inclusion
- Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.
Exclusion
- Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
693 Patients enrolled
Trial Details
Trial ID
NCT00643149
Start Date
May 1 2003
End Date
March 1 2004
Last Update
May 17 2011
Active Locations (46)
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1
Pfizer Investigational Site
Hoover, Alabama, United States, 35244
2
Pfizer Investigational Site
Pelham, Alabama, United States, 35124
3
Pfizer Investigational Site
Fresno, California, United States, 93710
4
Pfizer Investigational Site
Fresno, California, United States, 93720