A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.
An Open-label, Multi-center, Non-comparative Sinus Puncture Study of 750 mg, Short-course Levofloxacin in the Treatment of Acute Maxillary Sinusitis
1 other identifier
interventional
18
0 countries
N/A
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 infections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2003
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedJune 10, 2011
April 1, 2010
October 7, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1016/j.diagmicrobio.2006.10.019.
PMID: 17178300RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
November 1, 2003
Study Completion
June 1, 2005
Last Updated
June 10, 2011
Record last verified: 2010-04