Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare compliance between patients with Acute Bacterial Sinusitis (ABS) 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 ABS in outpatient clinic practice.

Official Title
-----------------
Non-Interventional Open Label Prospective Comparative Observational Study Of Evaluation Of Compliance In The Empiric Treatment With Azithromycin SR Versus Amoxiclav 1000 Mg In Adult Patients With Of Acute Bacterial Maxillary Sinusitis

Conditions
-----------------
Maxillary Sinusitis

Intervention / Treatment
-----------------
* Drug: Azithromycin SR
* Drug: Amoxiclav 1000 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or nor pregnant or lactating female outpatients, 18 years of age or older. A clinical diagnosis of acute bacterial uncomplicated maxillary sinusitis as demonstrated by presence of the following signs and symptoms for a minimum duration of 7-10 days: Facial pain, pressure and/or tightness over one or both maxillary sinuses, and/or pain in one or both maxillary areas that worsens with movement or percussion, and Presence of one or more of the following signs: i.purulent nasal discharge ii.purulent drainage in the posterior pharynx iii.purulent discharge from the maxillary sinus orifice A sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis. At least one of the following must be documented in one or both maxillary sinuses on radiologic examination: complete or partial opacification an air/fluid level Two or more of the following: fever, as defined by temperature: >38ºC leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR; headache, nasal congestion and post nasal drainage. Exclusion Criteria: Known or suspected hypersensitivity or intolerance or contraindications to Azithromycin, Amoxiclav according to LPDs, pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Azithromycin SR<br>Acute Bacterial Maxillary Sinusitis | Drug: Azithromycin SR<br>* Azithromycin SR, 2.0 g by mouth (PO) x 1<br>|
| Amoxiclav 1000 mg<br>Acute Bacterial Maxillary Sinusitis | Drug: Amoxiclav 1000 mg<br>* Amoxiclav 1000 mg x twice daily, 10 days<br>|

What is the study measuring?
-----------------
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'. | Day 11 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Compliance 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). | Day 11 | 
| 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. | Day 11 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis