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

Pfizer30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Community-Acquired Pneumonia

Interventions

Azithromycin SRDRUG

Azithromycin SR, 2.0 g PO x 1 dose for treatment period

AmoxiclavDRUG

Amoxiclav 1000 x twice daily, 10 days duration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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'.

Time frame: Days 11-12

Secondary Outcomes

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).

Time frame: Days 11-12

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.

Time frame: Days 11-12

Data from ClinicalTrials.gov

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