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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00643539
First received: March 19, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  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 4

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

Resource links provided by NLM:


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
Experimental: 1 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
Experimental: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Pfizer Investigational Site
Ancenis, France, 44150
Pfizer Investigational Site
Asnieres Sur Seine, France, 92600
Pfizer Investigational Site
Auch, France, 32000
Pfizer Investigational Site
Boulogne, France, 92100
Pfizer Investigational Site
Brest, France, 29200
Pfizer Investigational Site
Brive, France, 19100
Pfizer Investigational Site
Cannes La Boca, France, 06150
Pfizer Investigational Site
Chalons En Champagne, France, 51000
Pfizer Investigational Site
Chambery, France, 73000
Pfizer Investigational Site
Champigny sur Marne, France, 94500
Pfizer Investigational Site
Combs La Ville, France, 77380
Pfizer Investigational Site
Dijon, France, 21000
Pfizer Investigational Site
Draguignan, France, 33170
Pfizer Investigational Site
Draguignan, France, 83300
Pfizer Investigational Site
Essey Les Nancy, France, 54270
Pfizer Investigational Site
Lagny, France, 77400
Pfizer Investigational Site
Les Sables D`olonne, France, 85100
Pfizer Investigational Site
Les Ulis, France, 91940
Pfizer Investigational Site
Levallois Perret, France, 92300
Pfizer Investigational Site
Marseille, France, 13013
Pfizer Investigational Site
Marseille, France, 13006
Pfizer Investigational Site
Marseille, France, 13014
Pfizer Investigational Site
Massy, France, 91300
Pfizer Investigational Site
Meudon La Foret, France, 92360
Pfizer Investigational Site
Meysieu, France, 69330
Pfizer Investigational Site
Millery, France, 69390
Pfizer Investigational Site
Nogent Sur Marne, France, 94130
Pfizer Investigational Site
Paris, France, 75004
Pfizer Investigational Site
Paris, France, 75019
Pfizer Investigational Site
Paris, France, 75020
Pfizer Investigational Site
Paris, France, 75005
Pfizer Investigational Site
Paris, France, 75015
Pfizer Investigational Site
Saint Marcel, France, 71380
Pfizer Investigational Site
Saint Quentin, France, 02100
Pfizer Investigational Site
Salon de Provence, France, 13300
Pfizer Investigational Site
Sartrouville, France, 78500
Pfizer Investigational Site
Selestat, France, 67600
Pfizer Investigational Site
Strasbourg, France, 67100
Pfizer Investigational Site
Thionville, France, 57100
Pfizer Investigational Site
Tours, France, 37000
Pfizer Investigational Site
Tresses, France, 33370
Pfizer Investigational Site
Vandoeuvre Les Nancy, France, 54500
Pfizer Investigational Site
Varois Et Chaignot, France, 21490
Pfizer Investigational Site
Vence, France, 06140
Pfizer Investigational Site
Versailles, France, 78000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Tonsillitis
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Pharyngitis
Respiratory Tract Diseases
Respiratory Tract Infections
Stomatognathic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014