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

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NCT00643539

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Study Location
Pfizer Investigational Site
Ancenis, , 44150, France
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Tonsillitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-15 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Patients with pseudomembranous, vesicular, ulcerous or ulceronecrotic pharyngitis were
excluded.

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TonsillitisMulticenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat NCT00643539
  1. Ancenis,
  2. Asnieres Sur Seine,
  3. Auch,
  4. Boulogne,
  5. Brest,
  6. Brive,
  7. Cannes La Boca,
  8. Chalons En Champagne,
  9. Chambery,
  10. Champigny sur Marne,
  11. Combs La Ville,
  12. Dijon,
  13. Draguignan,
  14. Draguignan,
  15. Essey Les Nancy,
  16. Lagny,
  17. Les Sables D`olonne,
  18. Les Ulis,
  19. Levallois Perret,
  20. Marseille,
  21. Marseille,
  22. Marseille,
  23. Massy,
  24. Meudon La Foret,
  25. Meysieu,
  26. Millery,
  27. Nogent Sur Marne,
  28. Paris,
  29. Paris,
  30. Paris,
  31. Paris,
  32. Paris,
  33. Saint Marcel,
  34. Saint Quentin,
  35. Salon de Provence,
  36. Sartrouville,
  37. Selestat,
  38. Strasbourg,
  39. Thionville,
  40. Tours,
  41. Tresses,
  42. Vandoeuvre Les Nancy,
  43. Varois Et Chaignot,
  44. Vence,
  45. Versailles,
ALL GENDERS
3 Years+
years
MULTIPLE SITES
TonsillitisA Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children NCT00643149
  1. Hoover, Alabama
  2. Pelham, Alabama
  3. Fresno, California
  4. Fresno, California
  5. San Diego, California
  6. Evansville, Indiana
  7. Evansville, Indiana
  8. Evansville, Indiana
  9. Newburgh, Indiana
  10. Newburgh, Indiana
  11. Wichita, Kansas
  12. Wichita, Kansas
  13. Bardstown, Kentucky
  14. Springfield, Kentucky
  15. Kalamazoo, Michigan
  16. Endwell, New York
  17. Raleigh, North Carolina
  18. Beachwood, Ohio
  19. Chesterland, Ohio
  20. Cleveland, Ohio
  21. Cleveland, Ohio
  22. Willoughby, Ohio
  23. Youngstown, Ohio
  24. McMurray, Pennsylvania
  25. Pittsburgh, Pennsylvania
  26. Pittsburgh, Pennsylvania
  27. Bryan, Texas
  28. Lake Jackson, Texas
  29. Salt Lake City, Utah
  30. Salt Lake City, Utah
  31. Salt Lake City, Utah
  32. Salt Lake City, Utah
  33. West Jordan, Utah
  34. Calgary, Alberta
  35. Coquitlam, British Columbia
  36. Winnipeg, Manitoba
  37. Saskatoon, Saskatchewan
  38. Escazu, San Jose
  39. La Uruca, San Jose
  40. San Jose,
  41. Guatemala,
  42. Hyderabad, Andhara Pradesh
  43. Bangalore, Karnataka
  44. Kochi, Kerala
  45. Mumbai, Maharashtra
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Multicenter, Open, Randomized Comparative Trial To Compare The Efficacy Of Azithromycin Versus Amoxicillin In Children With Strep Throat
Official Title  ICMJE Multicenter, Open, Randomized Comparative Trial To Compare Bacteriological And Clinical Efficacy Of Azithromycin Versus Amoxicillin In Children With Streptococcus Tonsillitis
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tonsillitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Clamoxyl
  • Experimental: 2
    Intervention: Drug: Zithromax
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2008)		360
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 3 Years to 15 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643539
Other Study ID Numbers  ICMJE A0661037
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP