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)

• ClinicalTrials.gov Identifier: NCT01032174
• Recruitment Status: Completed
• First Posted: December 15, 2009
• Results First Posted: March 22, 2012
• Last Update Posted: April 16, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Maxillary Sinusitis	Drug: Azithromycin SR; Drug: Amoxiclav 1000 mg

Study Design

• Study Type: Observational
• Actual Enrollment: 123 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Study Start Date: April 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Response of Very Convenient or Somewhat Convenient [ Time Frame: Day 11 ]
   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'.

Secondary Outcome Measures :

1. Percent Compliance With Prescribed Treatment Regimen [ Time Frame: Day 11 ]
   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).
2. Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen [ Time Frame: Day 11 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with Acute Maxillary Sinusitis

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:

  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.

Contacts and Locations

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01032174
• Other Study ID Numbers: A0661199
• First Posted: December 15, 2009
• Results First Posted: March 22, 2012
• Last Update Posted: April 16, 2012
• Last Verified: April 2012

Keywords provided by Pfizer:

Azithromycin SR Amoxiclav 1000 mg Maxillary Sinusitis

Additional relevant MeSH terms:

Sinusitis; Maxillary Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Azithromycin; Anti-Bacterial Agents; Anti-Infective Agents