Zmax Compared to Augmentin in Sinusitis

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will enroll patients with Bacterial Sinusitis who will be treated with either Zmax (Azithromycin Extended Release) or Augmentin (Amoxicillin/Clavulanate). The purpose of the study is to compare early resolution of symptoms between the two treatments. Patients will report resolution of their sinusitis symptoms through a daily questionnaire. There will be two follow-up telephone interviews on days 12 and 28 to evaluate quality of life, satisfaction with therapy, and use of healthcare services.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Clavulanic Acid; Clavulanic Acids

Criteria

Inclusion Criteria:

• A clinical diagnosis of acute uncomplicated bacterial maxillary sinusitis as demonstrated by presence of the following cardinal signs and symptoms for a minimum duration of 7 days, and no longer than 30 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:

• Discolored (yellow-green) nasal discharge

• Discolored (yellow-green) drainage in the posterior pharynx

• Discolored (yellow-green) discharge from the maxillary sinus orifice

• Two or more of the following symptoms are present:

• Fever, as defined by:

• Oral temperature: >38C or >100.4F, or

• Tympanic temperature: >38.5C or >101.2F

• Frequent coughing

• Nasal congestion,

• Post-nasal drainage.

Exclusion Criteria:

• Treatment with any systemic antibiotic within 30 days prior to enrollment

• Symptoms of sinusitis lasting for longer than 30 days;

• Four or more episodes of acute sinusitis within the preceding 12 months;