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Zmax Compared to Augmentin in Sinusitis

Information source: Pfizer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Sinusitis

Intervention: Azithromycin Extended Release (Drug); Amoxicillin/Clavulanate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.      

Clinical Details

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

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

Primary outcome: Patient reported symptom resolution at day 5

Secondary outcome: Time to symptom resolution.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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;

Locations and Contacts

Additional Information

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

Starting date: June 2006
Last updated: November 9, 2007

Page last updated: June 20, 2008

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