Status:
COMPLETED
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Sinusitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
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 levofl...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
784 Patients enrolled
Trial Details
Trial ID
NCT00236522
Start Date
October 1 2002
End Date
April 1 2004
Last Update
June 10 2011
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