A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

NCT00643409

Last updated date
Study Location
Pfizer Investigational Site
Alabaster, Alabama, 35007, 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.
Maxillary Sinusitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.

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


Patients were excluded if they were treated with any systemic antibiotic within 7 days
prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes
of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3
months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.

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Maxillary SinusitisA Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
NCT00643409
  1. Alabaster, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Hueytown, Alabama
  6. Montgomery, Alabama
  7. Montgomery, Alabama
  8. Pelham, Alabama
  9. Tuscaloosa, Alabama
  10. Tuscaloosa, Alabama
  11. Jonesboro, Arkansas
  12. Clovis, California
  13. Fresno, California
  14. Fresno, California
  15. San Diego, California
  16. San Diego, California
  17. San Diego, California
  18. Bridgeport, Connecticut
  19. Wichita, Kansas
  20. Louisville, Kentucky
  21. New Orleans, Louisiana
  22. Kalamazoo, Michigan
  23. Portage, Michigan
  24. Richland, Michigan
  25. Three Rivers, Michigan
  26. Jefferson City, Missouri
  27. Missoula, Montana
  28. Missoula, Montana
  29. Charlote, North Carolina
  30. Charlotte, North Carolina
  31. Cincinnati, Ohio
  32. Cincinnati, Ohio
  33. Dayton, Ohio
  34. Dayton, Ohio
  35. Eugene, Oregon
  36. Eugene, Oregon
  37. Medford, Oregon
  38. Morrisville, Pennsylvania
  39. Norristown, Pennsylvania
  40. Plymouth Meeting, Pennsylvania
  41. Orangeburg, South Carolina
  42. Nashville, Tennessee
  43. Amarillo, Texas
  44. Amarillo, Texas
  45. Amarillo, Texas
  46. Bryan, Texas
  47. El Paso, Texas
  48. Houston, Texas
  49. Houston, Texas
  50. Pasadena, Texas
  51. San Antonio, Texas
  52. San Antonio, Texas
  53. San Antonio, Texas
  54. Wichita Falls, Texas
  55. Wichita Falls, Texas
  56. Murray, Utah
  57. Salt Lake City, Utah
  58. Salt Lake City, Utah
  59. Salt Lake City, Utah
  60. Buenos Aires,
  61. Santiago,
  62. Bo. Aranjuez, San Jose
  63. Escazu, San Jose
  64. Guadalupe, San Jose
  65. La Uruca, San Jose
  66. San Jose,
  67. Prague 10,
  68. Prague 2,
  69. Prague 5,
  70. Tallinn,
  71. Tartu,
  72. Rostock,
  73. Bangalore, Karnataka
  74. Kochi, Kerala
  75. Lucknow, Uttar Pradesh
  76. Vilnius,
  77. Vilnius,
  78. Chihuahua,
  79. Bielsko-Biala,
  80. Katowice,
  81. Lublin,
  82. Poznan,
  83. Moscow,
  84. Moscow,
  85. Smolensk,
  86. Bratislava,
  87. Kosice,
  88. Martin,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration
Brief Summary The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.
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 Maxillary Sinusitis
Intervention  ICMJE
  • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
    Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose
  • Other: placebo
    placebo
  • Drug: levofloxacin
    levofloxacin 500 mg capsule by mouth qd x 10 days
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: azithromycin SR (Zithromax; compound: CP-62,993)
    • Other: placebo
  • Experimental: 2
    Interventions:
    • Drug: levofloxacin
    • Other: 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: May 10, 2011)
541
Original Actual Enrollment  ICMJE
 (submitted: March 19, 2008)
504
Actual Study Completion Date  ICMJE February 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage.

Exclusion Criteria:

Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (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 Argentina,   Chile,   Costa Rica,   Czech Republic,   Estonia,   Germany,   India,   Lithuania,   Mexico,   Poland,   Russian Federation,   Slovakia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00643409
Other Study ID Numbers  ICMJE A0661078
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