Status:
COMPLETED
Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat
Lead Sponsor:
Pfizer
Conditions:
Tonsillitis
Eligibility:
All Genders
3-15 years
Phase:
PHASE4
Brief Summary
The primary objective was to compare the bacteriological efficacy at Day 10 of azithromycin pediatric suspension (20 mg/kg/day once daily for 3 consecutive days) versus amoxicillin pediatric suspensio...
Eligibility Criteria
Inclusion
- Outpatients with an acute pharyngitis erythematous or erythematopultaceous with modification of pharynx aspect and fever of ≥38° C, and patients either with or without spontaneous pharyngeal pain or upon swallowing and enlargement of the cervical lymph node (mandibular area) were eligible for inclusion. All subjects should have had a positive rapid strep test and a positive culture for Group A beta-hemolytic streptococcus.
Exclusion
- Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT00643539
Start Date
December 1 2002
End Date
July 1 2003
Last Update
March 26 2008
Active Locations (45)
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1
Pfizer Investigational Site
Ancenis, France, 44150
2
Pfizer Investigational Site
Asnières-sur-Seine, France, 92600
3
Pfizer Investigational Site
Auch, France, 32000
4
Pfizer Investigational Site
Boulogne, France, 92100