Zmax Compared to Augmentin in Sinusitis

A Multicenter, Randomized, Open Label Comparative Study Of Azithromycin Extended Release (ZMAX) Versus Amoxicillin/Clavulanate Potassium In Subjects With Acute Bacterial Sinusitis (ABS) In A Physician Practice Environment

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.

Study Overview

• Status: Completed
• Conditions: Sinusitis
• Intervention / Treatment: Drug: Azithromycin Extended Release; Drug: Amoxicillin/Clavulanate

• Study Type: Interventional
• Enrollment (Actual): 762
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Patient reported symptom resolution at day 5

Secondary Outcome Measures

Outcome Measure
Time to symptom resolution.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Study Completion (Actual): February 1, 2007

Study Registration Dates

• First Submitted: August 21, 2006
• First Submitted That Met QC Criteria: August 21, 2006
• First Posted (Estimate): August 22, 2006

Study Record Updates

• Last Update Posted (Estimate): March 16, 2010
• Last Update Submitted That Met QC Criteria: March 15, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin; Azithromycin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: A0661180