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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00643539

Purpose

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.

Condition	Intervention	Phase
Tonsillitis	Drug: Zithromax Drug: Clamoxyl	Phase IV

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Azithromycin Amoxicillin Amoxicillin sodium Amoxicillin trihydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis

Further study details as provided by Pfizer:

Primary Outcome Measures:

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 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Bacteriological success or failure rate [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
Clinical success or failure rate [ Time Frame: Day 30 ] [ Designated as safety issue: No ]
Serious and non-serious adverse events (AEs) rates [ Time Frame: continuous ] [ Designated as safety issue: Yes ]
Rate of poststreptococcal complications and new disease occurrence since Day 10 [ Time Frame: Day 30 ]

Enrollment:	360
Study Start Date:	December 2002
Study Completion Date:	July 2003

Arms	Assigned Interventions
1: Experimental	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
2: Experimental	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

Eligibility

Ages Eligible for Study:	3 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643539

Locations

France
Pfizer Investigational Site
BRIVE, France, 19100
Pfizer Investigational Site
CHAMBERY, France, 73000
Pfizer Investigational Site
ESSEY LES NANCY, France, 54270
Pfizer Investigational Site
VENCE, France, 06140
Pfizer Investigational Site
CANNES LA BOCA, France, 06150
Pfizer Investigational Site
DIJON, France, 21000
Pfizer Investigational Site
AUCH, France, 32000
Pfizer Investigational Site
TRESSES, France, 33370
Pfizer Investigational Site
COMBS LA VILLE, France, 77380
Pfizer Investigational Site
NOGENT SUR MARNE, France, 94130
Pfizer Investigational Site
SAINT QUENTIN, France, 02100
Pfizer Investigational Site
BOULOGNE, France, 92100
Pfizer Investigational Site
CHALONS EN CHAMPAGNE, France, 51000
Pfizer Investigational Site
SALON DE PROVENCE, France, 13300
Pfizer Investigational Site
LES SABLES D`OLONNE, France, 85100
Pfizer Investigational Site
MASSY, France, 91300
Pfizer Investigational Site
TOURS, France, 37000
Pfizer Investigational Site
MARSEILLE, France, 13006
Pfizer Investigational Site
PARIS, France, 75020
Pfizer Investigational Site
PARIS, France, 75019
Pfizer Investigational Site
LES ULIS, France, 91940
Pfizer Investigational Site
DRAGUIGNAN, France, 83300
Pfizer Investigational Site
Champigny sur Marne, France, 94500
Pfizer Investigational Site
SAINT MARCEL, France, 71380
Pfizer Investigational Site
MARSEILLE, France, 13014
Pfizer Investigational Site
STRASBOURG, France, 67100
Pfizer Investigational Site
SELESTAT, France, 67600
Pfizer Investigational Site
ANCENIS, France, 44150
Pfizer Investigational Site
VAROIS ET CHAIGNOT, France, 21490
Pfizer Investigational Site
PARIS, France, 75015
Pfizer Investigational Site
BREST, France, 29200
Pfizer Investigational Site
THIONVILLE, France, 57100
Pfizer Investigational Site
VANDOEUVRE LES NANCY, France, 54500
Pfizer Investigational Site
LAGNY, France, 77400
Pfizer Investigational Site
MEYSIEU, France, 69330
Pfizer Investigational Site
DRAGUIGNAN, France, 33170
Pfizer Investigational Site
MILLERY, France, 69390
Pfizer Investigational Site
PARIS, France, 75004
Pfizer Investigational Site
PARIS, France, 75005
Pfizer Investigational Site
LEVALLOIS PERRET, France, 92300
Pfizer Investigational Site
MEUDON LA FORET, France, 92360
Pfizer Investigational Site
ASNIERES SUR SEINE, France, 92600
Pfizer Investigational Site
Sartrouville, France, 78500
Pfizer Investigational Site
Versailles, France, 78000
Pfizer Investigational Site
MARSEILLE, France, 13013

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0661037
Study First Received:	March 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00643539
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Amoxicillin
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Streptococcal Infections

Azithromycin
Tonsillitis
Stomatognathic Diseases
Pharyngeal Diseases

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009