Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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 A

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: Percentage of Participants With Response of Very Convenient or Somewhat Convenient [ Time Frame: Day 11 ]

Participant reported outcome questionnaire was the assessment of participant's convenience with drug treatment based on following categories: very convenient or somewhat convenient and not convenient or not at all convenient. Value of 1 was reported if participant answered 'very convenient' or 'somewhat convenient' and 0 if participant answered 'not convenient' or 'not at all convenient'.


Original Primary Outcome: The primary efficacy variable will be the percentage of enrolled patients who answer 'very convenient' or 'somewhat convenient' on question 4 of the Treatment Compliance Questionnaire at Visit 3. [ Time Frame: 10 days ]

Current Secondary Outcome:

  • Percent Compliance With Prescribed Treatment Regimen [ Time Frame: Day 11 ]
    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed).
  • Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen [ Time Frame: Day 11 ]
    Percent compliance with the prescribed treatment regimen was calculated as 100 multiplied by (number of tablets taken by the participant divided by number of tablets prescribed). Value of 1 was reported if percent compliance equals to 100, and 0 if percent compliance was non-missing and less than 100.


Original Secondary Outcome: Percent compliance with the prescribed treatment regimen, defined as: 100x(number of tablets taken)/(number of tablets prescribed). The percentage of enrolled patients who were 100% compliant with the prescribed treatment regimen. [ Time Frame: 10 days ]

Information By: Pfizer

Dates:
Date Received: December 14, 2009
Date Started: April 2010
Date Completion:
Last Updated: April 10, 2012
Last Verified: April 2012