Maxillary Sinusitis Clinical Trial
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | PriCara, Unit of Ortho-McNeil, Inc. |
Anon JB, Paglia M, Xiang J, Ambrose PG, Jones RN, Kahn JB. Serial sinus aspirate samples during high-dose, short-course levofloxacin treatment of acute maxillary sinusitis. Diagn Microbiol Infect Dis. 2007 Jan;57(1):105-7. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment. | |||
Secondary | 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. |
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