A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults

NCT00644293

Last updated date
Study Location
Pfizer Investigational Site
Clearwater, Florida, 33761, 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.
Pharyngitis, Tonsillitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
13 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or 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 treatment with any systemic antibiotic within the
previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known
carriers of GABHS.

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Pharyngitis, TonsillitisA Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
NCT00644293
  1. Clearwater, Florida
  2. Boise, Idaho
  3. Boise, Idaho
  4. Boise, Idaho
  5. Boise, Idaho
  6. Boise, Idaho
  7. Meridian, Idaho
  8. Nampa, Idaho
  9. Omaha, Nebraska
  10. Hickory, North Carolina
  11. Eugene, Oregon
  12. Bensalem, Pennsylvania
  13. Harleysville, Pennsylvania
  14. Salt Lake City, Utah
  15. Salt Lake City, Utah
  16. West Jordan, Utah
  17. Erembodegem,
  18. Gent,
  19. Hasselt,
  20. Nokia,
  21. Tampere,
  22. Courbevoie,
  23. Gentilly,
  24. Lille,
  25. Montpellier,
  26. Rouen,
  27. Villejuif,
  28. Berlin,
  29. Berlin,
  30. Erkner,
  31. Ludwigshafen,
  32. Ruedersdorf,
  33. Tostedt,
  34. Villingen-Schwenningen,
  35. Wuerzburg,
  36. Bangalore, Karnataka
  37. Kochi, Kerala
  38. Hyderabad,
  39. Pune,
  40. Foligno, PG
  41. Gualdo Tadino, PG
  42. S.Eraclio-Foligno, PG
  43. Spoleto, PG
  44. Vocabolo Gaifana-Gualdo Tadino, PG
  45. Ede (Gld),
  46. Geldermalsen,
  47. Huizen,
  48. Elverum,
  49. Skedsmokorset,
  50. Bath, Avon
  51. Hastings, East Sussex
  52. Glenrothes, Fife
  53. High Valleyfield, Fife
  54. Tunbrige Wells, Kent
  55. Atherstone, Warwickshire
  56. Coventry,
  57. Kent,
  58. Kent,
  59. Kent,
ALL GENDERS
13 Years+
years
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Pharyngitis, TonsillitisPASS Study To Evaluate The Potential Of Zithromax To Cause Ocular Problems In Pediatric Patients
NCT01919996
  1. Rancho Cordova, California
  2. Chicago, Illinois
  3. Chicago, Illinois
  4. Chicago, Illinois
  5. Murray, Utah
  6. Salt Lake City, Utah
ALL GENDERS
12 Years+
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MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin Sustained Release Versus 3-Day Azithromycin for the Treatment of Strep Throat in Adolescents and Adults
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Three-Day Azithromycin for the Treatment of Group A ?-Hemolytic Streptococcal Pharyngitis/Tonsillitis in Adolescents and Adults
Brief Summary To determine if a single 2.0-g dose of azithromycin SR is at least as effective as a 3-day course of azithromycin (500 mg once daily for 3 days) when used to treat adolescents and adults with strep throat, and to assess efficacy and safety for both treatment regimens.
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
  • Pharyngitis
  • Tonsillitis
Intervention  ICMJE
  • Drug: azithromycin (Zithromax)
    azithromycin 500 mg tablet by mouth once daily for 3 days
  • Drug: placebo
    placebo
  • Drug: azithromycin SR
    azithromycin SR 2.0 g by mouth as an oral slurry for 1 dose
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: azithromycin (Zithromax)
    • Drug: placebo
  • Experimental: 2
    Interventions:
    • Drug: azithromycin SR
    • Drug: placebo
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)
598
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with evidence of acute group A beta-hemolytic streptococcus (GABHS) pharyngitis/tonsillitis and a positive rapid antigen detection test or positive culture of the pharynx or tonsils for GABHS

Exclusion Criteria:

  • Patients were excluded if they had treatment with any systemic antibiotic within the previous 7 days, a history of rheumatic fever, a peritonsillar abcess, or were known carriers of GABHS.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   France,   Germany,   India,   Italy,   Netherlands,   Norway,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00644293
Other Study ID Numbers  ICMJE A0661119
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial 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 June 2011

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