A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children

NCT00643149

Last updated date
Study Location
Pfizer Investigational Site
Hoover, Alabama, 35244, United States
Contact
1-800-718-1021

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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
2-12 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.

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


Patients were excluded if they had previously diagnosed disease(s) of immune function or
treatment with any systemic antibiotic within the previous 7 days.

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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 A Multicenter, Randomized, Double-Blind, Double-Dummy Study Of Azithromycin SR Versus Amoxicillin For The Treatment Of Strep Throat In Children
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial Of Azithromycin SR Versus Amoxicillin For The Treatment Of Group A ?-Hemolytic Streptococcal Pharyngitis/Tonsillitis In Children
Brief Summary The objective was to determine if a single 60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin (45 mg/kg/day, given in divided doses every 12 hours) when used to treat children with strep throat.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tonsillitis
Intervention  ICMJE
  • Drug: amoxicillin
    10 day regimen, 45 mg/kg/day, given in divided doses every 12 hours
  • Drug: azithromycin SR
    60 mg/kg dose of azithromycin SR was as safe and effective as a 10-day regimen of amoxicillin when used to treat children with strep throat
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: amoxicillin
  • Experimental: 2
    Intervention: Drug: azithromycin SR
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: May 16, 2011)
693
Original Actual Enrollment  ICMJE
 (submitted: March 19, 2008)
626
Actual Study Completion Date  ICMJE March 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients who had evidence of acute pharyngitis/tonsillitis based on erythematous pharyngeal mucosa or thick exudate covering the pharynx and tonsillar area, and at least one of the following signs or symptoms were included: sore/scratchy throat; pain on swallowing; chills and/or fever cervical adenopathy; scarlet fever rash on the face and skin folds, or red tongue with prominent papillae ("strawberry tongue"). Subjects were required to have a positive rapid antigen detection test (RADT) or a positive culture of the pharynx or tonsils for GABHS.

Exclusion Criteria:

Patients were excluded if they had previously diagnosed disease(s) of immune function or treatment with any systemic antibiotic within the previous 7 days.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Costa Rica,   Guatemala,   India,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643149
Other Study ID Numbers  ICMJE A0661071
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 May 2011

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