Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat
1 other identifier
interventional
360
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2002
Shorter than P25 for phase_4
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
March 19, 2008
CompletedFirst Posted
Study publicly available on registry
March 26, 2008
CompletedMarch 26, 2008
March 1, 2008
March 19, 2008
March 19, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
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
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
Eligibility Criteria
You may not qualify if:
- Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were excluded.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (45)
Pfizer Investigational Site
Ancenis, 44150, France
Pfizer Investigational Site
Asnières-sur-Seine, 92600, France
Pfizer Investigational Site
Auch, 32000, France
Pfizer Investigational Site
Boulogne, 92100, France
Pfizer Investigational Site
Brest, 29200, France
Pfizer Investigational Site
Brivé, 19100, France
Pfizer Investigational Site
Cannes LA BOCA, 06150, France
Pfizer Investigational Site
Chambéry, 73000, France
Pfizer Investigational Site
Champigny-sur-Marne, 94500, France
Pfizer Investigational Site
Châlons-en-Champagne, 51000, France
Pfizer Investigational Site
Combs-la-Ville, 77380, France
Pfizer Investigational Site
Dijon, 21000, France
Pfizer Investigational Site
Draguignan, 33170, France
Pfizer Investigational Site
Draguignan, 83300, France
Pfizer Investigational Site
Essey-lès-Nancy, 54270, France
Pfizer Investigational Site
Lagny, 77400, France
Pfizer Investigational Site
Les Sables-d'Olonne, 85100, France
Pfizer Investigational Site
Les Ulis, 91940, France
Pfizer Investigational Site
Levallois-Perret, 92300, France
Pfizer Investigational Site
Marseille, 13006, France
Pfizer Investigational Site
Marseille, 13013, France
Pfizer Investigational Site
Marseille, 13014, France
Pfizer Investigational Site
Massy, 91300, France
Pfizer Investigational Site
Meudon-la-Forêt, 92360, France
Pfizer Investigational Site
Meysieu, 69330, France
Pfizer Investigational Site
Millery, 69390, France
Pfizer Investigational Site
Nogent-sur-Marne, 94130, France
Pfizer Investigational Site
Paris, 75004, France
Pfizer Investigational Site
Paris, 75005, France
Pfizer Investigational Site
Paris, 75015, France
Pfizer Investigational Site
Paris, 75019, France
Pfizer Investigational Site
Paris, 75020, France
Pfizer Investigational Site
Saint-Marcel, 71380, France
Pfizer Investigational Site
Saint-Quentin, 02100, France
Pfizer Investigational Site
Salon-de-Provence, 13300, France
Pfizer Investigational Site
Sartrouville, 78500, France
Pfizer Investigational Site
Sélestat, 67600, France
Pfizer Investigational Site
Strasbourg, 67100, France
Pfizer Investigational Site
Thionville, 57100, France
Pfizer Investigational Site
Tours, 37000, France
Pfizer Investigational Site
Tresses, 33370, France
Pfizer Investigational Site
Vandœuvre-lès-Nancy, 54500, France
Pfizer Investigational Site
Varois-et-Chaignot, 21490, France
Pfizer Investigational Site
Vence, 06140, France
Pfizer Investigational Site
Versailles, 78000, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 19, 2008
First Posted
March 26, 2008
Study Start
December 1, 2002
Study Completion
July 1, 2003
Last Updated
March 26, 2008
Record last verified: 2008-03