A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults

Study Overview
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Brief Summary
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The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with uncomplicated, acute bacterial sinus infections, and to evaluate the safety of both treatments.

Official Title
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A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Acute Bacterial Maxillary Sinusitis in Adults Undergoing Diagnostic Sinus Aspiration

Conditions
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Maxillary Sinusitis

Intervention / Treatment
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* Drug: azithromycin SR (Zithromax; compound: CP-62,993)
* Other: placebo
* Drug: levofloxacin
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients were included if they had a clinical diagnosis of acute bacterial maxillary sinusitis as demonstrated by presence of the cardinal signs and symptoms for a minimum duration of 7 days, a sinus X-ray (Water's view) confirming the clinical diagnosis of maxillary sinusitis, and 2 or more of following: fever, leukocytosis, frequent coughing, headache, nasal congestion, or post-nasal drainage. Exclusion Criteria: Patients were excluded if they were treated with any systemic antibiotic within 7 days prior to enrollment, had symptoms lasting for longer than 28 days, had 4 or more episodes of acute sinusitis within the preceding 12 months, had nasal or sinus surgery within 3 months prior (except for a diagnostic procedure), or complicated or nosocomial sinusitis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: azithromycin SR (Zithromax; compound: CP-62,993)<br>* Azithromycin SR 2.0 g by mouth in the form of a slurry x 1 dose<br>Other: placebo<br>* placebo<br>|
| Experimental: 2<br> | Drug: levofloxacin<br>* levofloxacin 500 mg capsule by mouth qd x 10 days<br>Other: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sponsor assessment of clinical response for the Clinical per Protocol population |  | Test of Cure (TOC) visit (Day 17-24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population |  | EOT visit and TOC visit | 
| investigator assessment of clinical response for the Clinical per Protocol population |  | TOC visit | 
| bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population |  | TOC visit | 
| summary of baseline susceptibilities |  | Study endpoint | 
| adverse events |  | Continuous | 
| laboratory abnormalities |  | during and post-treatment | 
| sponsor assessment of clinical response for the Clinical per Protocol population |  | End of Treatment (EOT) visit (Day 11-13) | 
| sponsor assessment of clinical response for the remaining study populations |  | EOT visit and TOC visit |