A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses
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: Sinusitis; 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 & 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 safety and effectiveness of levofloxacin, an
antibiotic, compared with amoxicillin/clavulanate potassium in the treatment of adults with
rapid onset of severe inflammation/infection of the sinuses.
Clinical Details
Official title: A Multicenter, Randomized Study to Compare the Safety and Efficacy of Oral Levofloxacin With Amoxicillin/Clavulanate Potassium in the Treatment of Acute Sinusitis in Adults
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Clinical response rate (a reduction in signs and symptoms, and stabilization/improvement of sinus x-ray results) at post-therapy visit, 2 - 5 days after the last dose of study drug
Secondary outcome: Incidence of adverse events; change in physical examination, and laboratory tests from the start of the study to after treatment
Detailed description:
Levofloxacin is an antibacterial agent used for the treatment of many types of severe
infections with rapid onset and brief duration in adults. This is a randomized, open-label,
parallel group, multicenter study to determine the safety and effectiveness of levofloxacin
(500 mg tablets once daily by mouth for 10 - 14 days) compared with amoxicillin/clavulanate
(500 mg/125 mg tablets by mouth every 8 hours for 10 - 14 days) in adults with rapid onset
of severe inflammation/infection of the sinuses. The study consists of 4 visits: one visit
for screening and enrollment, and three visits to assess the safety and effectiveness of
treatment (one telephone contact during Days 3 - 6 of the study [if no significant
improvement in symptoms has occurred by that time, a visit is scheduled]; one visit
[post-therapy] 2 - 5 days after the last dose of the study drug; and one visit [post-study]
28 - 32 days after the last dose of the study drug). The total duration of patient
participation in the study is approximately 6 weeks. The primary measure of effectiveness is
assessed by the clinical response rate after the completion of treatment (a reduction in the
signs and symptoms, and by stabilization or improvement in x-ray findings). Safety
evaluations (incidence of adverse events, physical examination, and laboratory tests) are
performed throughout the study. The study hypothesis is that treatment with levofloxacin is
at least as effective and as well tolerated as treatment with amoxicillin/clavulanate
potassium in adults with rapid onset of severe inflammation/infection of the sinuses. 500 mg
tablets of levofloxacin by mouth once daily, or 500 mg/125 mg amoxicillin/clavulanate
tablets by mouth every 8 hours. The duration of treatment is 10 - 14 days.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Diagnosis of rapid onset of severe inflammation/infection of the sinuses, as
indicated by: fever, headache, discharge from the nose containing pus, facial pain,
or tenderness in the area of the cheek bone
- x-ray at the start of the trial consistent with the diagnosis of severe
inflammation/infection of the sinuses
- able to take oral medications
Exclusion Criteria:
- Patients with symptoms of sinusitis that has persisted longer than 4 weeks or who
have had more than 2 previous episodes of rapid onset of severe
inflammation/infection of the sinuses within 12 months prior to the trial
- previous allergic or serious adverse reaction to similar antibiotics
- specific blood and urine test results indicating kidney problems
- requirement of an antibiotic medication taken internally in addition to the study
drug or have taken antibiotic medication within 48 hours prior to the start of the
study and have experienced improvement
- seizure disorders or any condition requiring tranquilizers.
Locations and Contacts
Additional Information
A study of the safety and effectiveness of levofloxacin compared with amoxicillin/clavulanate potassium in the treatment of adults with rapid onset of severe inflammation/infection of the sinuses
Starting date: August 1993
Last updated: June 8, 2011
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