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

Tracking Information

• First Submitted Date: December 14, 2009
• First Posted Date: December 15, 2009
• Results First Submitted Date: February 21, 2012
• Results First Posted Date: March 22, 2012
• Last Update Posted Date: April 16, 2012
• Study Start Date: April 2010
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 21, 2012)

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'.

• Original Primary Outcome Measures (submitted: December 14, 2009): The primary efficacy variable will be the percentage of enrolled patients who answer 'very convenient' or 'somewhat convenient' on question 4 of the Treatment Compliance Questionnaire at Visit 3. [ Time Frame: 10 days ]

Current Secondary Outcome Measures (submitted: February 21, 2012)

• 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).
• 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.

• Original Secondary Outcome Measures (submitted: December 14, 2009): Percent compliance with the prescribed treatment regimen, defined as: 100x(number of tablets taken)/(number of tablets prescribed). The percentage of enrolled patients who were 100% compliant with the prescribed treatment regimen. [ Time Frame: 10 days ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with Acute Maxillary Sinusitis
• Condition: Maxillary Sinusitis

Intervention

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

Study Groups/Cohorts

• Azithromycin SR
  Acute Bacterial Maxillary Sinusitis
  Intervention: Drug: Azithromycin SR
• Amoxiclav 1000 mg
  Acute Bacterial Maxillary Sinusitis
  Intervention: Drug: Amoxiclav 1000 mg

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 9, 2011): 123
• Original Estimated Enrollment (submitted: December 14, 2009): 120
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

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:

  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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01032174
• Other Study ID Numbers: A0661199
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: April 2012