Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236821
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2005-10-07
Brief Title:
A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None