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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 123
- Primary Endpoint
- Percentage of Participants With Response of Very Convenient or Somewhat Convenient
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •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.
Arms & Interventions
Azithromycin SR
Acute Bacterial Maxillary Sinusitis
Intervention: Azithromycin SR (Drug)
Amoxiclav 1000 mg
Acute Bacterial Maxillary Sinusitis
Intervention: Amoxiclav 1000 mg (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Percent Compliance With Prescribed Treatment Regimen(Day 11)
- Percentage of Participants Who Were 100 Percent Compliant With Prescribed Treatment Regimen(Day 11)