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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:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01032694
First received: December 14, 2009
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  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:

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032694

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

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01032694     History of Changes
Other Study ID Numbers: A0661200
Study First Received: December 14, 2009
Results First Received: November 21, 2011
Last Updated: November 21, 2011
Health Authority: Russia: Ethics Committee

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

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Azithromycin
 Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013