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

Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis

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.

Study Overview

• Status: Completed
• Conditions: Tonsillitis
• Intervention / Treatment: Drug: Clamoxyl; Drug: Zithromax

• Study Type: Interventional
• Enrollment (Actual): 360
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Ancenis, France, 44150
    • Pfizer Investigational Site
  • Asnieres Sur Seine, France, 92600
    • Pfizer Investigational Site
  • Auch, France, 32000
    • Pfizer Investigational Site
  • Boulogne, France, 92100
    • Pfizer Investigational Site
  • Brest, France, 29200
    • Pfizer Investigational Site
  • Brive, France, 19100
    • Pfizer Investigational Site
  • Cannes La Boca, France, 06150
    • Pfizer Investigational Site
  • Chalons En Champagne, France, 51000
    • Pfizer Investigational Site
  • Chambery, France, 73000
    • Pfizer Investigational Site
  • Champigny sur Marne, France, 94500
    • Pfizer Investigational Site
  • Combs La Ville, France, 77380
    • Pfizer Investigational Site
  • Dijon, France, 21000
    • Pfizer Investigational Site
  • Draguignan, France, 33170
    • Pfizer Investigational Site
  • Draguignan, France, 83300
    • Pfizer Investigational Site
  • Essey Les Nancy, France, 54270
    • Pfizer Investigational Site
  • Lagny, France, 77400
    • Pfizer Investigational Site
  • Les Sables D'olonne, France, 85100
    • Pfizer Investigational Site
  • Les Ulis, France, 91940
    • Pfizer Investigational Site
  • Levallois Perret, France, 92300
    • Pfizer Investigational Site
  • Marseille, France, 13006
    • Pfizer Investigational Site
  • Marseille, France, 13013
    • Pfizer Investigational Site
  • Marseille, France, 13014
    • Pfizer Investigational Site
  • Massy, France, 91300
    • Pfizer Investigational Site
  • Meudon La Foret, France, 92360
    • Pfizer Investigational Site
  • Meysieu, France, 69330
    • Pfizer Investigational Site
  • Millery, France, 69390
    • Pfizer Investigational Site
  • Nogent Sur Marne, France, 94130
    • Pfizer Investigational Site
  • Paris, France, 75004
    • Pfizer Investigational Site
  • Paris, France, 75005
    • Pfizer Investigational Site
  • Paris, France, 75015
    • Pfizer Investigational Site
  • Paris, France, 75019
    • Pfizer Investigational Site
  • Paris, France, 75020
    • Pfizer Investigational Site
  • Saint Marcel, France, 71380
    • Pfizer Investigational Site
  • Saint Quentin, France, 02100
    • Pfizer Investigational Site
  • Salon de Provence, France, 13300
    • Pfizer Investigational Site
  • Sartrouville, France, 78500
    • Pfizer Investigational Site
  • Selestat, France, 67600
    • Pfizer Investigational Site
  • Strasbourg, France, 67100
    • Pfizer Investigational Site
  • Thionville, France, 57100
    • Pfizer Investigational Site
  • Tours, France, 37000
    • Pfizer Investigational Site
  • Tresses, France, 33370
    • Pfizer Investigational Site
  • Vandoeuvre Les Nancy, France, 54500
    • Pfizer Investigational Site
  • Varois Et Chaignot, France, 21490
    • Pfizer Investigational Site
  • Vence, France, 06140
    • Pfizer Investigational Site
  • Versailles, France, 78000
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: Clamoxyl; Amoxicillin (Clamoxyl) pediatric formulation (500 mg/5 ml) administered as an oral suspension at a dose of 25 mg/kg twice daily (maximal dose 2 g/day) for 6 consecutive days
Experimental: 2	Drug: Zithromax; azithromycin (Zithromax) pediatric suspension formulation (200 mg/5 ml) administered as an oral suspension at a dose of 20 mg/kg once a day (maximal dose 500 mg/day) for 3 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion: December 7, 2022
• Study Completion (Actual): July 1, 2003

Study Registration Dates

• First Submitted: March 19, 2008
• First Submitted That Met QC Criteria: March 19, 2008
• First Posted (Estimate): March 26, 2008

Study Record Updates

• Last Update Posted (Estimate): March 26, 2008
• Last Update Submitted That Met QC Criteria: March 19, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Tonsillitis; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin; Azithromycin
• Other Study ID Numbers: A0661037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No