A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses

• Status: Completed
• Trial end date: 1994-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of levofloxacin, an antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses.

• 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: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Clavulanic Acid; Clavulanic Acids; Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Diagnosis of rapid onset of severe inflammation/infection of the sinuses, as indicated by: fever, headache, discharge from the nose containing pus, facial pain, or tenderness in the area of the cheek bone

• x-ray at the start of the trial consistent with the diagnosis of severe inflammation/infection of the sinuses

• able to take oral medications

Exclusion Criteria:

• Patients with symptoms of sinusitis that has persisted longer than 4 weeks or who have had more than 2 previous episodes of rapid onset of severe inflammation/infection of the sinuses within 12 months prior to the trial

• previous allergic or serious adverse reaction to similar antibiotics

• specific blood and urine test results indicating kidney problems

• requirement of an antibiotic medication taken internally in addition to the study drug or have taken antibiotic medication within 48 hours prior to the start of the study and have experienced improvement

• seizure disorders or any condition requiring tranquilizers.