Zmax Compared to Augmentin in Sinusitis

Phase 4

Completed

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 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Patient reported symptom resolution at day 5

Secondary Outcome Measures

Name	Time	Method
Time to symptom resolution.

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