A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.

• Status: Completed
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of a once-daily administration of 750 milligrams levofloxacin (an antibiotic) for five days, in treating bacterial sinus infections.

• 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:

• Clinical signs and symptoms of acute maxillary sinusitis for 5 to 28 days

• Visible nasal purulence evident on physical examination

• CT scan or standard sinus x-ray (Waters' projections) performed within 5 days prior to the first dose of study drug, showing total sinus opacification or an air-fluid level

• Agree to a maxillary sinus puncture and catheter placement

• If female, using birth control

Exclusion Criteria:

• Chronic sinusitis

• Need for hospitalization or intravenous antibiotics

• History of head, neck, or nasal cancer or surgery

• Previous allergy, serious adverse reaction to, or failed therapy with, levofloxacin or any other member of the quinolone class

• Presence or history of serious complications of sinusitis

• Previous antimicrobial therapy within 7 days of Study Entry