Non-Interventional Open Label Prospective Observational Comparative Study On Evaluation Of Compliance Of The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Mild To Moderate Community Acquired Pneumonia

Terminated

• Conditions: Community-Acquired Pneumonia
• Interventions: Drug: Azithromycin SR; Drug: Amoxiclav

• Registration Number: NCT01032694
• Lead Sponsor: Pfizer

Brief Summary

To compare compliance between patients with CAP 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 CAP in outpatient clinic practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-14
• Study First Submitted QC: 2009-12-14
• Study First Posted: 2009-12-15
• Study Start: 2010-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-11
• Results First Submitted: 2011-11-21
• Results First Submitted QC: 2011-11-21
• Last Update Submitted: 2011-11-21
• Results First Posted: 2011-12-21
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Males or not pregnant or lactating females, 18 years of age or older, for whom oral antibacterial therapy is indicated with clinically evidence of Diagnosis of pneumonia, based on usual clinical practice:

  1. Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales).
  2. Body temperature >38 degrees C.

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Z-max treated group	Azithromycin SR	Patients with Community-Acquired Pneumonia
Amoxiclav treated group	Amoxiclav	Patients with Community-Acquired Pneumonia

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Response of Very Convenient or Somewhat Convenient	Days 11-12	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'.

Secondary Outcome Measures

Name	Time	Method
Percent Compliance With the Prescribed Treatment Regimen	Days 11-12	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	Days 11-12	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.