Overview

Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat

Status:
Completed

Trial end date:
2003-07-01

Target enrollment:
0

Participant gender:
All

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 suspension (50 mg/kg/day in 2 doses for 6 consecutive days) in children aged 3-15 years with Group A streptococcal acute pharyngitis/tonsillitis. Secondary objectives were assessments of bacteriological efficacy at Day 30 and clinical efficacy at Day 10 and Day 30.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Amoxicillin
Azithromycin

Criteria

Inclusion Criteria:

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 Criteria:

Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were
excluded.