Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

NCT01032174

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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

- Male or nor pregnant or lactating female outpatients, 18 years of age or older.

- A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:

1. Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and

2. Presence of one or more of the following signs:

i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice

- A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:

1. complete or partial opacification

2. an air/fluid level

Two or more of the following:

1. fever, as defined by temperature: >38ºC

2. leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;

3. headache,

4. nasal congestion and post nasal drainage.

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


- Known or suspected hypersensitivity or intolerance or contraindications to
Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.

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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 Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
Official Title Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis
Brief Summary The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) treated with Azithromycin SR 2.0 g single dose orally and those treated with Amoxiclav - 1000 mg twice daily 10 days for the empiric treatment of ABS in outpatient clinic practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with Acute Maxillary Sinusitis
Condition Maxillary Sinusitis
Intervention
  • Drug: Azithromycin SR
    Azithromycin SR, 2.0 g by mouth (PO) x 1
  • Drug: Amoxiclav 1000 mg
    Amoxiclav 1000 mg x twice daily, 10 days
Study Groups/Cohorts
  • Azithromycin SR
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Azithromycin SR
  • Amoxiclav 1000 mg
    Acute Bacterial Maxillary Sinusitis
    Intervention: Drug: Amoxiclav 1000 mg
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 Completed
Actual Enrollment
 (submitted: June 9, 2011)
123
Original Estimated Enrollment
 (submitted: December 14, 2009)
120
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male or nor pregnant or lactating female outpatients, 18 years of age or older.
  • A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days:

    1. Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and
    2. Presence of one or more of the following signs:

    i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice

  • A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination:

    1. complete or partial opacification
    2. an air/fluid level

Two or more of the following:

  1. fever, as defined by temperature: >38ºC
  2. leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;
  3. headache,
  4. nasal congestion and post nasal drainage.

Exclusion Criteria:

  • Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01032174
Other Study ID Numbers A0661199
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2012