Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Azithromycin Extended Release
• Drug: Amoxicillin/Clavulanate

Primary Measures

• Patient reported symptom resolution at day 5

Secondary Measures

• Time to symptom resolution.

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;

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367120

Study ID Number: A0661180

ClinicalTrials.gov Identifier: NCT00367120

Health Authority: United States: Food and Drug Administration

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