A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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.
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.
Clinical Details
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: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Eligibility
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
Locations and Contacts
Additional Information
An Open-Label, Non-Comparative Sinus Puncture Study of 750 MG, Short-Course Levofloxacin in Acute Maxillary Sinusitis
Starting date: November 2003
Last updated: June 8, 2011
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