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

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Azithromycin SR
  • Azithromycin SR, 2.0 g PO x 1 dose for treatment period
• Drug: Amoxiclav
  • Amoxiclav 1000 x twice daily, 10 days duration

Arms, Groups and Cohorts in this Clinical Trial

• : Z-max treated group
  • Patients with Community-Acquired Pneumonia
• : Amoxiclav treated group
  • Patients with Community-Acquired Pneumonia

Primary Measures

• Percentage of Participants With Response of Very Convenient or Somewhat Convenient
  • Time Frame: Days 11-12
    Safety Issue?: No

Secondary Measures

• Percent Compliance With the Prescribed Treatment Regimen
  • Time Frame: Days 11-12
    Safety Issue?: No
• Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen
  • Time Frame: Days 11-12
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01032694

Study ID Number: A0661200

ClinicalTrials.gov Identifier: NCT01032694

Health Authority: Russia: Ethics Committee

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