A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.

• Status: Completed
• Trial end date: 2004-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: PriCara, Unit of Ortho-McNeil, Inc.
• Treatments: Levofloxacin; Ofloxacin

Criteria

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