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)

• ClinicalTrials.gov Identifier: NCT01032694
• Recruitment Status: Terminated
• First Posted: December 15, 2009
• Results First Posted: December 21, 2011
• Last Update Posted: December 21, 2011
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Community-Acquired Pneumonia	Drug: Azithromycin SR; Drug: Amoxiclav

Study Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• 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
• Study Start Date: April 2010
• Actual Primary Completion Date: December 2010
• Actual Study Completion Date: December 2010

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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).
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• 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

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. 

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01032694
• Other Study ID Numbers: A0661200
• First Posted: December 15, 2009
• 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; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Azithromycin; Anti-Bacterial Agents; Anti-Infective Agents