Zmax Compared to Augmentin in Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367120
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : March 16, 2010
Information provided by:

August 21, 2006
August 22, 2006
March 16, 2010
June 2006
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Patient reported symptom resolution at day 5
Same as current
Complete list of historical versions of study NCT00367120 on Archive Site
Time to symptom resolution.
Same as current
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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.
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Drug: Azithromycin Extended Release
  • Drug: Amoxicillin/Clavulanate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 2007
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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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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United States
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Director, Clinical Trial Disclosure Group, Pfizer, Inc.
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Study Director: Pfizer Call Center Pfizer
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP