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

NCT ID: NCT00643539

Last Updated: 2008-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2003-07-31

Brief Summary

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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

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Conditions

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Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Clamoxyl

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

Zithromax

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Ancenis, , France

Site Status

Pfizer Investigational Site

Asnières-sur-Seine, , France

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Pfizer Investigational Site

Auch, , France

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Boulogne, , France

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Brest, , France

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Brivé, , France

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Cannes LA BOCA, , France

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Chambéry, , France

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Champigny-sur-Marne, , France

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Châlons-en-Champagne, , France

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Combs-la-Ville, , France

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Dijon, , France

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Draguignan, , France

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Draguignan, , France

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Essey-lès-Nancy, , France

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Lagny, , France

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Les Sables-d'Olonne, , France

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Les Ulis, , France

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Levallois-Perret, , France

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Marseille, , France

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Marseille, , France

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Marseille, , France

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Massy, , France

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Meudon-la-Forêt, , France

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Meysieu, , France

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Millery, , France

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Nogent-sur-Marne, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Saint-Marcel, , France

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Saint-Quentin, , France

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Salon-de-Provence, , France

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Sartrouville, , France

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Sélestat, , France

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Strasbourg, , France

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Thionville, , France

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Tours, , France

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Pfizer Investigational Site

Tresses, , France

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Vandœuvre-lès-Nancy, , France

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Pfizer Investigational Site

Varois-et-Chaignot, , France

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Pfizer Investigational Site

Vence, , France

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Pfizer Investigational Site

Versailles, , France

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Countries

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France

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0661037&StudyName=Multicenter%2C%20Open%2C%20Randomized%20Comparative%20Trial%20To%20Compare%20The%20Efficacy%20Of%20Azithromycin%20Versus%20Amoxicillin%20In%20Children%20With%20Strep%20Throat

To obtain contact information for a study center near you, click here.

Other Identifiers

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A0661037

Identifier Type: -

Identifier Source: org_study_id