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

Maxillary Sinusitis Clinical Trial

— EASY  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01032174
• Other study ID #: A0661199
• Status: Completed
• Phase: N/A
• First received: December 14, 2009
• Last updated: April 10, 2012
• Start date: April 2010
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

1. 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

2. 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:

1. complete or partial opacification

2. an air/fluid level

Two or more of the following:

1. fever, as defined by temperature: >38ºC

2. leukocytosis [White Blood Cell (WBC) >10,000/mm3 or >15% band forms], ECR;

3. headache,

4. 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Maxillary Sinusitis
• Sinusitis

Intervention

Drug:
• Azithromycin SR
Azithromycin SR, 2.0 g by mouth (PO) x 1
• Amoxiclav 1000 mg
Amoxiclav 1000 mg x twice daily, 10 days

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'.	Day 11	No
Secondary	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	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.	Day 11	No

External Links

•   To obtain contact information for a study center near you, click here.