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NCT00643539 Clinical Trial

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

Tonsillitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00643539
Other study ID # A0661037
Secondary ID
Status Completed
Phase Phase 4
First received March 19, 2008
Last updated March 19, 2008
Start date December 2002
Est. completion date July 2003

Study information
Verified date March 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 360
Est. completion date July 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 15 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• 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

Locations
Country Name City State
France Pfizer Investigational Site Ancenis
France Pfizer Investigational Site Asnieres Sur Seine
France Pfizer Investigational Site Auch
France Pfizer Investigational Site Boulogne
France Pfizer Investigational Site Brest
France Pfizer Investigational Site Brive
France Pfizer Investigational Site Cannes La Boca
France Pfizer Investigational Site Chalons En Champagne
France Pfizer Investigational Site Chambery
France Pfizer Investigational Site Champigny sur Marne
France Pfizer Investigational Site Combs La Ville
France Pfizer Investigational Site Dijon
France Pfizer Investigational Site Draguignan
France Pfizer Investigational Site Draguignan
France Pfizer Investigational Site Essey Les Nancy
France Pfizer Investigational Site Lagny
France Pfizer Investigational Site Les Sables D`olonne
France Pfizer Investigational Site Les Ulis
France Pfizer Investigational Site Levallois Perret
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Marseille
France Pfizer Investigational Site Massy
France Pfizer Investigational Site Meudon La Foret
France Pfizer Investigational Site Meysieu
France Pfizer Investigational Site Millery
France Pfizer Investigational Site Nogent Sur Marne
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Paris
France Pfizer Investigational Site Saint Marcel
France Pfizer Investigational Site Saint Quentin
France Pfizer Investigational Site Salon de Provence
France Pfizer Investigational Site Sartrouville
France Pfizer Investigational Site Selestat
France Pfizer Investigational Site Strasbourg
France Pfizer Investigational Site Thionville
France Pfizer Investigational Site Tours
France Pfizer Investigational Site Tresses
France Pfizer Investigational Site Vandoeuvre Les Nancy
France Pfizer Investigational Site Varois Et Chaignot
France Pfizer Investigational Site Vence
France Pfizer Investigational Site Versailles

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Bacteriological success or failure rate Day 30 No
Secondary 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 No
Secondary Clinical success or failure rate Day 30 No
Secondary Serious and non-serious adverse events (AEs) rates continuous Yes
Secondary Rate of poststreptococcal complications and new disease occurrence since Day 10 Day 30
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Completed NCT02712307 - Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci Phase 4
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Active, not recruiting NCT01691690 - Analgesic Effect of IV Acetaminophen in Tonsillectomies Phase 2
Completed NCT00393744 - Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children Phase 3
Completed NCT00095368 - APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat Phase 3
Active, not recruiting NCT00136877 - Tonsillectomy in Recurrent Tonsillitis N/A
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Completed NCT01361399 - Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold Phase 3
Recruiting NCT03137823 - Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface N/A
Completed NCT02571075 - Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea N/A
Completed NCT00547391 - Recurrent Throat Infections and Tonsillectomy Phase 4
Completed NCT00242281 - APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat Phase 3
Completed NCT01465009 - Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold Phase 4
Recruiting NCT04164511 - Does Ice Cream Help With Post-tonsillectomy Pain
Completed NCT04653376 - Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases

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