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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Tonsillitis

Treatments

Drug: Clamoxyl

Drug: Zithromax

Study type

Interventional

Funder types

Industry

Identifiers

NCT00643539

A0661037

Details and patient eligibility

About

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.

Enrollment

360 patients

Sex

All

Ages

3 to 15 years old

Volunteers

No Healthy Volunteers

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.