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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

When treating sinus infections (sinusitis) caused by bacteria, the traditional duration of therapy is between 10 and 14 days. In this randomized, double-blind study, 5 days of 750 milligrams of levofloxacin given once daily will be compared to 10 days of 500 milligrams of levofloxacin in the treatment of non-hospitalized adult patients who have acute bacterial sinusitis. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study.

Patients will have a sinus specimen collected at the first visit. Safety evaluations will be conducted. The objective of the study is to demonstrate that, in the treatment of acute bacterial sinus infections, a 5-day course of 750 milligrams of levofloxacin given once daily is at least as effective as a 10-day course of 500 milligrams of levofloxacin given once daily and is well tolerated.

Patients will take by mouth 750 milligrams levofloxacin capsules once daily for 5 days followed by placebo capsules once daily for 5 days, or 500 milligrams levofloxacin capsules once daily for 10 days.

Intervention(s) in this Clinical Trial

• Drug: levofloxacin

Primary Measures

• Clinical success (resolution of patient signs and symptoms) at the post-therapy visit.

Secondary Measures

• Microbiologic response at the post-therapy visit and safety evaluations.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236522

Study ID Number: CR002809

ClinicalTrials.gov Identifier: NCT00236522

Health Authority: United States: Food and Drug Administration

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