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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Community-Acquired Pneumonia

Intervention / Treatment
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* Drug: Azithromycin SR
* Drug: Amoxiclav


Participation Criteria
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Eligibility Criteria
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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: Physical examination and auscultatory findings (dullness on percussion, bronchial breath sounds, egophony, dry or fine most rales). 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Z-max treated group<br>Patients with Community-Acquired Pneumonia | Drug: Azithromycin SR<br>* Azithromycin SR, 2.0 g PO x 1 dose for treatment period<br>|
| Amoxiclav treated group<br>Patients with Community-Acquired Pneumonia | Drug: Amoxiclav<br>* Amoxiclav 1000 x twice daily, 10 days duration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community-Acquired Pneumonia, Azithromycin SR, Amoxiclav