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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tonsillitis

Intervention: Zithromax (Drug); Clamoxyl (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

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

Primary outcome: 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

Secondary outcome:

Bacteriological success or failure rate

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

Clinical success or failure rate

Serious and non-serious adverse events (AEs) rates

Rate of poststreptococcal complications and new disease occurrence since Day 10

Eligibility

Minimum age: 3 Years. Maximum age: 15 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Pfizer Investigational Site, Ancenis 44150, France

Pfizer Investigational Site, Asnieres 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, Brive 19100, France

Pfizer Investigational Site, Cannes La Boca 06150, France

Pfizer Investigational Site, Chalons En Champagne 51000, France

Pfizer Investigational Site, Chambery 73000, France

Pfizer Investigational Site, Champigny sur Marne 94500, 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 Les 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 Foret 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, Selestat 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, Vandoeuvre Les Nancy 54500, France

Pfizer Investigational Site, Varois Et Chaignot 21490, France

Pfizer Investigational Site, Vence 06140, France

Pfizer Investigational Site, Versailles 78000, France

Additional Information

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

Starting date: December 2002
Last updated: March 19, 2008

Page last updated: August 23, 2015

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