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 (EASY)

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.

Study Overview

• Status: Completed
• Conditions: Maxillary Sinusitis
• Intervention / Treatment: Drug: Azithromycin SR; Drug: Amoxiclav 1000 mg

• Study Type: Observational
• Enrollment (Actual): 123

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with Acute Maxillary Sinusitis

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Azithromycin SR; Acute Bacterial Maxillary Sinusitis	Drug: Azithromycin SR; Azithromycin SR, 2.0 g by mouth (PO) x 1
Amoxiclav 1000 mg; Acute Bacterial Maxillary Sinusitis	Drug: Amoxiclav 1000 mg; Amoxiclav 1000 mg x twice daily, 10 days

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: December 14, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 15, 2009

Study Record Updates

• Last Update Posted (Estimate): April 16, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Maxillary Sinusitis; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: A0661199