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)

Pfizer

Status: Completed

Conditions: Maxillary Sinusitis

Treatments: Drug: Azithromycin SR; Drug: Amoxiclav 1000 mg

Study type: Observational

Funder types: Industry

Identifiers

NCT01032174

A0661199

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

123 participants in 2 patient groups

Azithromycin SR

Description:

Acute Bacterial Maxillary Sinusitis

Treatment:

Drug: Azithromycin SR

Amoxiclav 1000 mg

Description:

Acute Bacterial Maxillary Sinusitis

Treatment:

Drug: Amoxiclav 1000 mg