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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

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Maxillary Sinusitis; Sinusitis

Intervention: levofloxacin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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.

Clinical Details

Official title: A Multicenter, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With Amoxicillin/Clavulanate Potassium in the Treatment of Acute Sinusitis in Adults

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Clinical response rate (a reduction in signs and symptoms, and stabilization/improvement of sinus x-ray results) at post-therapy visit, 2 - 5 days after the last dose of study drug

Secondary outcome: Incidence of adverse events; change in physical examination, and laboratory tests from the start of the study to after treatment

Detailed description: Levofloxacin is an antibacterial agent used for the treatment of many types of severe infections with rapid onset and brief duration in adults. This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin

(500 mg tablets once daily by mouth for 10 - 14 days) compared with amoxicillin/clavulanate

(500 mg/125 mg tablets by mouth every 8 hours for 10 - 14 days) in adults with rapid onset of

severe inflammation/infection of the sinuses. The study consists of 4 visits: one visit for screening and enrollment, and three visits to assess the safety and effectiveness of

treatment (one telephone contact during Days 3 - 6 of the study [if no significant

improvement in symptoms has occurred by that time, a visit is scheduled]; one visit

[post-therapy] 2 - 5 days after the last dose of the study drug; and one visit [post-study]

28 - 32 days after the last dose of the study drug). The total duration of patient

participation in the study is approximately 6 weeks. The primary measure of effectiveness is assessed by the clinical response rate after the completion of treatment (a reduction in the signs and symptoms, and by stabilization or improvement in x-ray findings). Safety evaluations (incidence of adverse events, physical examination, and laboratory tests) are performed throughout the study. The study hypothesis is that treatment with levofloxacin is at least as effective and as well tolerated as treatment with amoxicillin/clavulanate potassium in adults with rapid onset of severe inflammation/infection of the sinuses.

500 mg tablets of levofloxacin by mouth once daily, or 500 mg/125 mg amoxicillin/clavulanate

tablets by mouth every 8 hours. The duration of treatment is 10 - 14 days.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

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


Ending date: July 1994
Last updated: May 11, 2007

Page last updated: June 20, 2008

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