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

Condition(s) targeted: Maxillary 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.

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.

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

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

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

Secondary outcome: 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.

Detailed description: 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

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

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

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

Starting date: November 2003
Ending date: June 2005
Last updated: April 17, 2008