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

Community-Acquired Pneumonia Clinical Trial

— PROSTO  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01032694
• Other study ID #: A0661200
• Status: Terminated
• Phase: N/A
• First received: December 14, 2009
• Last updated: November 21, 2011
• Start date: April 2010
• Est. completion date: December 2010

Study information

• Verified date: November 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Community-Acquired Pneumonia
• Pneumonia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Response of Very Convenient or Somewhat Convenient	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'.	Days 11-12	No
Secondary	Percent Compliance With the Prescribed Treatment Regimen	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).	Days 11-12	No
Secondary	Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen	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.	Days 11-12	No

External Links

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