A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.
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|ClinicalTrials.gov Identifier: NCT00236522|
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : June 10, 2011
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis||Drug: levofloxacin||Phase 3|
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 levofloxacin given once daily will be compared to 10 days of 500 milligrams of levofloxacin in the treatment of non-hospitalized adult patients who have acute bacterial sinusitis. To prevent the study doctor, study staff and patients from knowing which study drug they are taking, all study drug will manufactured to look the same and patients on the 5-day regimen will be given placebo for the last 5 days of their participation in the study. Patients will have a sinus specimen collected at the first visit. Safety evaluations will be conducted. The objective of the study is to demonstrate that, in the treatment of acute bacterial sinus infections, a 5-day course of 750 milligrams of levofloxacin given once daily is at least as effective as a 10-day course of 500 milligrams of levofloxacin given once daily and is well tolerated.
Patients will take by mouth 750 milligrams levofloxacin capsules once daily for 5 days followed by placebo capsules once daily for 5 days, or 500 milligrams levofloxacin capsules once daily for 10 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||784 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Levofloxacin 750 mg Once Daily for 5 Days Versus Levofloxacin 500 mg Once Daily for 10 Days in the Treatment of Acute Bacterial Sinusitis in Adults.|
|Study Start Date :||October 2002|
|Actual Study Completion Date :||April 2004|
- Clinical success (resolution of patient signs and symptoms) at the post-therapy visit.
- Microbiologic response at the post-therapy visit and safety evaluations.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236522
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|