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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 (PROSTO)

This study has been terminated.
(This study was terminated January 11, 2011 due to low enrollment. This study is not being terminated because of safety or efficacy concerns.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01032694
First Posted: December 15, 2009
Last Update Posted: December 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention
Community-Acquired Pneumonia Drug: Azithromycin SR Drug: Amoxiclav

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With Response of Very Convenient or Somewhat Convenient [ Time Frame: 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:
  • Percent Compliance With the Prescribed Treatment Regimen [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 30
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Z-max treated group
Patients with Community-Acquired Pneumonia
Drug: Azithromycin SR
Azithromycin SR, 2.0 g PO x 1 dose for treatment period
Amoxiclav treated group
Patients with Community-Acquired Pneumonia
Drug: Amoxiclav
Amoxiclav 1000 x twice daily, 10 days duration

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Community-Acquired Pneumonia.
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032694


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01032694     History of Changes
Other Study ID Numbers: A0661200
First Submitted: December 14, 2009
First Posted: December 15, 2009
Results First Submitted: November 21, 2011
Results First Posted: December 21, 2011
Last Update Posted: December 21, 2011
Last Verified: November 2011

Keywords provided by Pfizer:
Community-Acquired Pneumonia
Azithromycin SR
Amoxiclav

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections