Official Title: “An Open-Label, Multi-Center, Non-Comparative Sinus Puncture Study of 750 mg, Short-Course Levofloxacin in the Treatment of Acute Maxillary Sinusitis”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study

Acute bacterial sinusitis is a common diagnosis for which an antibiotic is prescribed in outpatients. Some types of bacteria that cause sinusitis are resistant to penicillin and certain other classes of antibiotics, but may be treatable with the antibiotic levofloxacin.

This will be an open-label, multi-center, non-comparative clinical trial involving outpatients with protocol-defined acute bacterial sinusitis suitable for treatment with oral antibiotics. At the Preliminary Visit, a sinus radiograph will be obtained to confirm the clinical diagnosis of sinusitis, and the Investigator will perform a nasal exam. Sinus puncture and placement of an indwelling sinus catheter into an affected maxillary sinus will be performed on all eligible patients at the first visit. Patients meeting the study criteria will receive 750 milligrams levofloxacin tablets once daily for 5 days. The primary objective is to establish the rate and extent of bacteriological eradication, defined as eradication of pathogens from the maxillary sinus, and to establish the effectiveness and safety of once-daily 750 milligrams levofloxacin for the treatment of acute bacterial sinusitis in adults.

Levofloxacin 750 milligram tablet orally once a day for 5 days

Intervention(s) in this Clinical Trial

• Drug: levofloxacin

Primary Measures

• Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.

Secondary Measures

• Efficacy: Clinical response on Day 5 and at the Post-Therapy Visit (Days 12-19); plasma and sinus aspirate concentrations on Days 2-4; levels of inflammatory mediators on Days 0-5. Safety: Adverse events, vital signs, and clinical laboratory tests.

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

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 October 06, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236652

Study ID Number: CR004678

ClinicalTrials.gov Identifier: NCT00236652

Health Authority: United States: Food and Drug Administration

An Open-Label, Non-Comparative Sinus Puncture Study of 750 MG, Short-Course Levofloxacin in Acute Maxillary Sinusitis