Sinusitis Clinical Trial
Official title:
A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Levofloxacin 750 mg Once Daily for 5 Days Versus Levofloxacin 500 mg Once Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults.
The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of acute bacterial sinusitis (sinus infection) in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given by mouth once daily will be compared to a 10-day course of 500 milligrams of levofloxacin given by mouth once daily.
Status | Completed |
Enrollment | 784 |
Est. completion date | April 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of acute bacterial sinusitis, defined by clinical signs and symptoms lasting for less than 28 days and the presence of visible nasal infection, and confirmed by computed tomography (CT) or standard sinus x-rays - Two or fewer episodes of bacterial sinusitis within the preceding 12 months - Willing to undergo maxillary sinus puncture or endoscopy Exclusion Criteria: - Chronic sinusitis - Use of systemic antibiotics within the past 72 hours - Presence or history of serious complications of sinusitis - Surgery for treating sinusitis - Required daily use of more than 20 milligrams of prednisone (oral steroid) - Cystic fibrosis |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PriCara, Unit of Ortho-McNeil, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical success (resolution of patient signs and symptoms) at the post-therapy visit. | |||
Secondary | Microbiologic response at the post-therapy visit and safety evaluations. |
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