Status:
COMPLETED
A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Maxillary Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 infection...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00236652
Start Date
November 1 2003
End Date
June 1 2005
Last Update
June 10 2011
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