NCT00367120CompletedPhase 4
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 762
- Primary Endpoint
- Patient reported symptom resolution at day 5
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Outcomes
Primary Outcomes
Patient reported symptom resolution at day 5
Secondary Outcomes
- Time to symptom resolution.
Investigators
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