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
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