Pneumonia Clinical Trial
Official title:
Multicenter, Double-Blind Randomized Study to Compare the Safety and Efficacy of Levofloxacin 750 mg Once Daily for Five Days vs. Levofloxacin 500 mg Once Daily for 10 Days in the Treatment of Mild to Severe Community-Acquired Pneumonia in Adults
The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of community-acquired pneumonia in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a 10-day course 500 milligrams of levofloxacin given once daily.
Levofloxacin is an antibiotic that is approved by the FDA for the treatment of sinusitis,
chronic bronchitis, skin infections, urinary tract infections, and community-acquired
pneumonia. This multicenter, double-blind (neither the patient nor the study doctor will
know the dose of levofloxacin being administered) study evaluates the effectiveness and
safety of two antibiotic regimens in the treatment of community-acquired pneumonia in adult
patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared
to a 10-day course 500 milligrams of levofloxacin given once daily. Patients receive
levofloxacin by mouth or through a vein depending on the severity of their pneumonia.
Patients are assessed after 3 days of treatment; treatment is discontinued if no significant
improvement is noted. Patients showing signs of improvement continue in the study, with
assessments on study days 12-16, and 17-21 (posttherapy visits), and 31-38 (poststudy
visit). Effectiveness is assessed by measuring the ability of the study drug to eliminate
bacteria causing pneumonia and to reduce the signs and symptoms of pneumonia. Chest x-rays
and laboratory tests for presence of bacteria are performed during the study. Safety
evaluations (incidence of adverse events, physical examinations, laboratory tests) are
performed throughout the study. The study hypothesis is that levofloxacin administered at a
higher dose for a shorter duration is at least as effective as levofloxacin administered at
a lower dose for a longer duration in the treatment of community-acquired pneumonia and is
generally well-tolerated.
Levofloxacin, 500 milligrams (mg) by mouth or through vein daily for 10 days or 750 mg by
mouth or slowly through a vein daily for 5 days
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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