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

Phase 4

Completed

• Conditions: Tonsillitis
• Interventions: Drug: Clamoxyl; Drug: Zithromax

• Registration Number: NCT00643539
• Lead Sponsor: Pfizer

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Study Completion: 2003-07
• Status Verified: 2008-03
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Last Update Submitted: 2008-03-19
• Study First Posted: 2008-03-26
• Last Update Posted: 2008-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clamoxyl	-
2	Zithromax	-

Primary Outcome Measures

Name	Time	Method
Bacteriologic success (Eradication: elimination of the original GABS; or Colonization: elimination of the original GABS but isolation of another stain of GABS) or failure (Persistence: presence of original GABS on repeated culture samples) rate	Day 10

Secondary Outcome Measures

Name	Time	Method
Bacteriological success or failure rate	Day 30
Clinical success (resolution of signs and symptoms, or sufficient improvement; no additional antibacterial therapy indicated) or failure (insufficient improvement or worsening of signs and symptoms; additional antibacterial therapy indicated) rate	Day 10
Clinical success or failure rate	Day 30
Serious and non-serious adverse events (AEs) rates	continuous
Rate of poststreptococcal complications and new disease occurrence since Day 10	Day 30

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇫🇷 Versailles, France