Status:
COMPLETED
Zmax Compared to Augmentin in Sinusitis
Lead Sponsor:
Pfizer
Conditions:
Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 com...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
762 Patients enrolled
Trial Details
Trial ID
NCT00367120
Start Date
June 1 2006
End Date
February 1 2007
Last Update
March 16 2010
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